Kidney Failure, Chronic Therapy; Hemodialysis
Conditions
Keywords
Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
Brief summary
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
Detailed description
* A total of 48 healthy volunteers will be studied. * Depending on the safety profile at completion of the highest dose cohort, an additional 2 cohorts of subjects may be studied. * Doses of SFP may be modified, depending on the PK and safety findings at each dose level. * Cohorts may be dropped for safety or tolerability after discussion with the sponsor. * There will be 6 active and 2 placebo subjects in each study cohort. * Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion over 4 hours. * Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion over 12 hours. All subjects will be confined in the CRC for 1 day prior to study drug administration and for 2 additional days for safety assessments and completion of test procedures.
Interventions
DRUGPlacebo
Sponsors
Rockwell Medical Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-55 inclusive at the time of consent. This inclusion criterion will only be assessed at the first screening visit. 2. Male or non-pregnant, non-lactating female who is at least 90 days post-partum. 3. Subject is willing to comply with any applicable contraceptive requirements of the protocol. 4. Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination (PE), vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator. 5. An understanding, ability and willingness to fully comply with study procedures and restrictions. 6. Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures. 7. Body Mass Index (BMI) between 20.0 and 32.0 kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit. 8. Subjects must agree to discontinue all iron preparations for 14 days prior to study drug administration.
Exclusion criteria
1. Current or recurrent disease (e.g. cardiovascular, renal, liver, gastro-intestinal, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments. 2. Hemoglobin \< 11 g/dL or Hematocrit \< 30%. 3. Serum iron concentration ≤ 70 µg/dL (male or female). 4. Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures. 5. Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product. 6. Current use of any medication (including prescription, over the counter \[OTC\], herbal or homeopathic preparations) within 14 days of first dose of investigational product. Exceptions are hormonal replacement therapy, hormonal contraceptives, acetaminophen and non-steroidal anti-inflammatory drugs. 7. Known or suspected intolerance or hypersensitivity to iron containing product(s). 8. History of alcohol or other substance abuse within the last year. 9. A positive screen for cotinine, alcohol or drugs of abuse. 10. Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day. 1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1.5 oz.). 11. A history of a positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen. 12. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product. 13. Routine consumption of more than five units of caffeine per day or subjects who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6-oz. cup of coffee, two 12-oz. cans of cola, one 12-oz. cup of tea, three 1-oz. chocolate bars. 14. Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product. 15. Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study. 16. Pregnancy or intention to become pregnant before completing all study drug treatment. 17. Current medical status that, in the investigators opinion, would preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | Baseline (1 day) | The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo) |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | 48 hours | Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | 48 hours | Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | 48 hours | Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | 48 hours | Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | 48 hours | Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | 48 hours | Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | 48 hours | Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | 48 hours | Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | 48 hours | Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | 48 hours | Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | 48 hours | Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | 48 hours | Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | 48 hours | Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 48 hours | Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 48 hours | Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 48 hours | Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 48 hours | Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 48 hours | Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 48 hours | Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 48 hours | Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 48 hours | Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohorts 1 - 6 Placebo A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5). | 12 |
| Cohort 1 SFP A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours. | 6 |
| Cohort 2 SFP A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours. | 6 |
| Cohort 3 SFP A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours. | 6 |
| Cohort 4 SFP A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours. | 6 |
| Cohort 5 SFP A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours. | 6 |
| Cohort 6 SFP A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours. | 6 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohorts 1 - 6 Placebo | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 12 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 5 Participants | 5 Participants | 6 Participants | 4 Participants | 9 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 48 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 23 Participants | 2 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 25 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 8 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 0 / 6 | 3 / 6 | 2 / 6 | 4 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
Time frame: Baseline (1 day)
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 306.583 mg/dL | Standard Deviation 35.1606 |
| Cohort 1 SFP | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 283.500 mg/dL | Standard Deviation 29.985 |
| Cohort 2 SFP | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 315.500 mg/dL | Standard Deviation 40.7909 |
| Cohort 3 SFP | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 348.333 mg/dL | Standard Deviation 59.9956 |
| Cohort 6 SFP | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 303.833 mg/dL | Standard Deviation 47.2966 |
| Cohort 4 SFP | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 314.571 mg/dL | Standard Deviation 52.6841 |
| Cohort 5 SFP | Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 304.167 mg/dL | Standard Deviation 53.2143 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 7.5 hrs | 3.3 micrograms/dL | Standard Deviation 14.5 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 3 hrs | 4.5 micrograms/dL | Standard Deviation 15.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -0.554 micrograms/dL | Standard Deviation 11.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -6.73 micrograms/dL | Standard Deviation 14.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | 6.32 micrograms/dL | Standard Deviation 11.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 10 hrs | 5.16 micrograms/dL | Standard Deviation 12.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | 1.17 micrograms/dL | Standard Deviation 12.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | 2.97 micrograms/dL | Standard Deviation 10 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | -3.37 micrograms/dL | Standard Deviation 4.87 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | 11 micrograms/dL | Standard Deviation 12.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | 6.31 micrograms/dL | Standard Deviation 20.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4.5 hrs | 0.0952 micrograms/dL | Standard Deviation 13.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | 5.07 micrograms/dL | Standard Deviation 19.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | 5.93 micrograms/dL | Standard Deviation 11.5 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | 12.7 micrograms/dL | Standard Deviation 21.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | 2.98 micrograms/dL | Standard Deviation 7.07 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 5 hrs | 1.01 micrograms/dL | Standard Deviation 15.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 8 hrs | 3.37 micrograms/dL | Standard Deviation 10.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | 3.92 micrograms/dL | Standard Deviation 9.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | 9.52 micrograms/dL | Standard Deviation 14.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | 6.55 micrograms/dL | Standard Deviation 20.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 10 hrs | 1.51 micrograms/dL | Standard Deviation 6.03 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -10.1 micrograms/dL | Standard Deviation 11.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | 7.69 micrograms/dL | Standard Deviation 26.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 7.5 hrs | -6.01 micrograms/dL | Standard Deviation 10.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 8 hrs | -2.43 micrograms/dL | Standard Deviation 9.75 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | -6.39 micrograms/dL | Standard Deviation 12.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -2.51 micrograms/dL | Standard Deviation 10.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -5.44 micrograms/dL | Standard Deviation 5.35 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | 0.353 micrograms/dL | Standard Deviation 22.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | 12 micrograms/dL | Standard Deviation 53.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -7.56 micrograms/dL | Standard Deviation 11.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | 4.85 micrograms/dL | Standard Deviation 12.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 3 hrs | -11.9 micrograms/dL | Standard Deviation 10.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | 2.82 micrograms/dL | Standard Deviation 12.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -13.2 micrograms/dL | Standard Deviation 19.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | 1.51 micrograms/dL | Standard Deviation 15.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | 1.17 micrograms/dL | Standard Deviation 9.66 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4.5 hrs | -9.79 micrograms/dL | Standard Deviation 26.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | -3.11 micrograms/dL | Standard Deviation 9.14 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 5 hrs | -10.7 micrograms/dL | Standard Deviation 11.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -7.54 micrograms/dL | Standard Deviation 8.74 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | -3.44 micrograms/dL | Standard Deviation 17.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -4.66 micrograms/dL | Standard Deviation 6.42 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -13.2 micrograms/dL | Standard Deviation 9.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -23.4 micrograms/dL | Standard Deviation 9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | -24.5 micrograms/dL | Standard Deviation 11.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 3 hrs | -35.6 micrograms/dL | Standard Deviation 9.85 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -35.7 micrograms/dL | Standard Deviation 16.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4.5 hrs | -32.9 micrograms/dL | Standard Deviation 16.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 5 hrs | -32.7 micrograms/dL | Standard Deviation 15 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -30.4 micrograms/dL | Standard Deviation 13.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 7.5 hrs | -13.9 micrograms/dL | Standard Deviation 13.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 8 hrs | -24 micrograms/dL | Standard Deviation 20.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | -8.02 micrograms/dL | Standard Deviation 7.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 10 hrs | -1.37 micrograms/dL | Standard Deviation 4.46 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | 1.43 micrograms/dL | Standard Deviation 5.26 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | -0.139 micrograms/dL | Standard Deviation 6.84 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | 3.51 micrograms/dL | Standard Deviation 10.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | 1.06 micrograms/dL | Standard Deviation 6.27 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | 5.47 micrograms/dL | Standard Deviation 5.98 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | 6.93 micrograms/dL | Standard Deviation 5.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -13.6 micrograms/dL | Standard Deviation 19.7 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -11 micrograms/dL | Standard Deviation 28 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -1.65 micrograms/dL | Standard Deviation 24.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 10 hrs | -4.22 micrograms/dL | Standard Deviation 31.2 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 5 hrs | -34 micrograms/dL | Standard Deviation 19.7 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | -1.4 micrograms/dL | Standard Deviation 23.6 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | -6.32 micrograms/dL | Standard Deviation 42.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4.5 hrs | -27 micrograms/dL | Standard Deviation 22 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | -1.3 micrograms/dL | Standard Deviation 30.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -24.3 micrograms/dL | Standard Deviation 23.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | -3.15 micrograms/dL | Standard Deviation 28.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 3 hrs | -23.7 micrograms/dL | Standard Deviation 30.1 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -4.74 micrograms/dL | Standard Deviation 7.01 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | -1.2 micrograms/dL | Standard Deviation 32.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | -26.9 micrograms/dL | Standard Deviation 29.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | 6.22 micrograms/dL | Standard Deviation 25.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -13.9 micrograms/dL | Standard Deviation 35.8 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | -6.43 micrograms/dL | Standard Deviation 31.1 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -7.65 micrograms/dL | Standard Deviation 21.8 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 8 hrs | -7.72 micrograms/dL | Standard Deviation 25.1 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 7.5 hrs | -27.4 micrograms/dL | Standard Deviation 44.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | -27 micrograms/dL | Standard Deviation 36 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -1.42 micrograms/dL | Standard Deviation 5.22 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 5 hrs | -2.92 micrograms/dL | Standard Deviation 15.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -7.54 micrograms/dL | Standard Deviation 3.74 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | 4.08 micrograms/dL | Standard Deviation 10.7 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4.5 hrs | 0.744 micrograms/dL | Standard Deviation 13.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 8 hrs | -5.74 micrograms/dL | Standard Deviation 11.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | 4.29 micrograms/dL | Standard Deviation 6.91 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | -0.472 micrograms/dL | Standard Deviation 16.2 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | -2.44 micrograms/dL | Standard Deviation 16.2 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -6.96 micrograms/dL | Standard Deviation 5.75 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | 9.36 micrograms/dL | Standard Deviation 8.63 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -4.92 micrograms/dL | Standard Deviation 6.33 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | 2.66 micrograms/dL | Standard Deviation 11.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | 4.74 micrograms/dL | Standard Deviation 14.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 3 hrs | -9.69 micrograms/dL | Standard Deviation 6.81 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 10 hrs | -5.56 micrograms/dL | Standard Deviation 11.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -7.16 micrograms/dL | Standard Deviation 13.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | -1.01 micrograms/dL | Standard Deviation 6.73 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | 4.16 micrograms/dL | Standard Deviation 9.23 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | -13.8 micrograms/dL | Standard Deviation 6.34 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 7.5 hrs | -5.09 micrograms/dL | Standard Deviation 16.5 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 356 micrograms/dL | Standard Deviation 44 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 10 hrs | 352 micrograms/dL | Standard Deviation 41.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 7.5 hrs | 347 micrograms/dL | Standard Deviation 56.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 348 micrograms/dL | Standard Deviation 51.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 8 hrs | 359 micrograms/dL | Standard Deviation 38.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 362 micrograms/dL | Standard Deviation 39.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 345 micrograms/dL | Standard Deviation 51.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 350 micrograms/dL | Standard Deviation 44.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 355 micrograms/dL | Standard Deviation 43.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 346 micrograms/dL | Standard Deviation 45.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 342 micrograms/dL | Standard Deviation 48.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 3 hrs | 348 micrograms/dL | Standard Deviation 43 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 364 micrograms/dL | Standard Deviation 43.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 341 micrograms/dL | Standard Deviation 41.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 348 micrograms/dL | Standard Deviation 41.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 344 micrograms/dL | Standard Deviation 41.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 340 micrograms/dL | Standard Deviation 61.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4.5 hrs | 359 micrograms/dL | Standard Deviation 45.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 344 micrograms/dL | Standard Deviation 52.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 5 hrs | 358 micrograms/dL | Standard Deviation 43.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 351 micrograms/dL | Standard Deviation 43 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 315 micrograms/dL | Standard Deviation 26 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 318 micrograms/dL | Standard Deviation 24.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 10 hrs | 317 micrograms/dL | Standard Deviation 26.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 318 micrograms/dL | Standard Deviation 28.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 3 hrs | 313 micrograms/dL | Standard Deviation 28.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 7.5 hrs | 318 micrograms/dL | Standard Deviation 27 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 324 micrograms/dL | Standard Deviation 27 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4.5 hrs | 324 micrograms/dL | Standard Deviation 35.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 304 micrograms/dL | Standard Deviation 46.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 8 hrs | 319 micrograms/dL | Standard Deviation 27.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 5 hrs | 318 micrograms/dL | Standard Deviation 27.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 312 micrograms/dL | Standard Deviation 27.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 316 micrograms/dL | Standard Deviation 30.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 318 micrograms/dL | Standard Deviation 29.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 312 micrograms/dL | Standard Deviation 29.4 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 314 micrograms/dL | Standard Deviation 30.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 319 micrograms/dL | Standard Deviation 26.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 316 micrograms/dL | Standard Deviation 31.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 312 micrograms/dL | Standard Deviation 31.9 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 320 micrograms/dL | Standard Deviation 30.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 301 micrograms/dL | Standard Deviation 40.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 8 hrs | 339 micrograms/dL | Standard Deviation 25.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 7.5 hrs | 332 micrograms/dL | Standard Deviation 29.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 334 micrograms/dL | Standard Deviation 23.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 328 micrograms/dL | Standard Deviation 24.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 334 micrograms/dL | Standard Deviation 22.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 330 micrograms/dL | Standard Deviation 29.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 3 hrs | 329 micrograms/dL | Standard Deviation 26.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 328 micrograms/dL | Standard Deviation 23.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4.5 hrs | 339 micrograms/dL | Standard Deviation 22.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 5 hrs | 338 micrograms/dL | Standard Deviation 24.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 338 micrograms/dL | Standard Deviation 24.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 338 micrograms/dL | Standard Deviation 29.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 10 hrs | 338 micrograms/dL | Standard Deviation 28.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 333 micrograms/dL | Standard Deviation 29.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 336 micrograms/dL | Standard Deviation 23.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 335 micrograms/dL | Standard Deviation 31.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 327 micrograms/dL | Standard Deviation 27.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 326 micrograms/dL | Standard Deviation 23.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 346 micrograms/dL | Standard Deviation 22.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 344 micrograms/dL | Standard Deviation 24.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 346 micrograms/dL | Standard Deviation 19.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 360 micrograms/dL | Standard Deviation 53.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 5 hrs | 352 micrograms/dL | Standard Deviation 42.6 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 347 micrograms/dL | Standard Deviation 56.6 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 352 micrograms/dL | Standard Deviation 53.1 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 350 micrograms/dL | Standard Deviation 52.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 340 micrograms/dL | Standard Deviation 51.2 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 370 micrograms/dL | Standard Deviation 54.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 348 micrograms/dL | Standard Deviation 53.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 356 micrograms/dL | Standard Deviation 48.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 362 micrograms/dL | Standard Deviation 50 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4.5 hrs | 337 micrograms/dL | Standard Deviation 46.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 8 hrs | 356 micrograms/dL | Standard Deviation 54.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 364 micrograms/dL | Standard Deviation 50.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 3 hrs | 344 micrograms/dL | Standard Deviation 52.8 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 7.5 hrs | 355 micrograms/dL | Standard Deviation 52.8 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 10 hrs | 355 micrograms/dL | Standard Deviation 52.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 351 micrograms/dL | Standard Deviation 47.2 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 351 micrograms/dL | Standard Deviation 46.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 353 micrograms/dL | Standard Deviation 27.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 356 micrograms/dL | Standard Deviation 53.6 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 344 micrograms/dL | Standard Deviation 54.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 348 micrograms/dL | Standard Deviation 37.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 10 hrs | 347 micrograms/dL | Standard Deviation 34.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 5 hrs | 350 micrograms/dL | Standard Deviation 37.9 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 344 micrograms/dL | Standard Deviation 33.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4.5 hrs | 352 micrograms/dL | Standard Deviation 35.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 350 micrograms/dL | Standard Deviation 25.8 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 341 micrograms/dL | Standard Deviation 37.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 357 micrograms/dL | Standard Deviation 38.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 344 micrograms/dL | Standard Deviation 39.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 3 hrs | 342 micrograms/dL | Standard Deviation 38.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 352 micrograms/dL | Standard Deviation 35.9 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 344 micrograms/dL | Standard Deviation 36.9 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 342 micrograms/dL | Standard Deviation 36.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 338 micrograms/dL | Standard Deviation 32.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 352 micrograms/dL | Standard Deviation 35.7 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 352 micrograms/dL | Standard Deviation 36.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 353 micrograms/dL | Standard Deviation 35 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 8 hrs | 348 micrograms/dL | Standard Deviation 34.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 7.5 hrs | 348 micrograms/dL | Standard Deviation 36.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 349 micrograms/dL | Standard Deviation 34.9 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 348 micrograms/dL | Standard Deviation 37.8 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 7.5 hrs | 26.27143 micrograms/dL | Standard Deviation 25.89638 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 46.3375 micrograms/dL | Standard Deviation 32.43362 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | 10.34714 micrograms/dL | Standard Deviation 16.82299 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 3 hrs | 41.3125 micrograms/dL | Standard Deviation 31.5142 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 5 hrs | 50.74714 micrograms/dL | Standard Deviation 39.71965 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -4.24286 micrograms/dL | Standard Deviation 15.34727 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | -11.7838 micrograms/dL | Standard Deviation 24.1043 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 43.75 micrograms/dL | Standard Deviation 39.09914 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | -11.8538 micrograms/dL | Standard Deviation 20.68082 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 18.87125 micrograms/dL | Standard Deviation 19.08355 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -16.7163 micrograms/dL | Standard Deviation 29.37565 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 10 hrs | -0.1875 micrograms/dL | Standard Deviation 18.48079 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 19.25243 micrograms/dL | Standard Deviation 12.97435 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | -14.525 micrograms/dL | Standard Deviation 23.13773 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 7.852857 micrograms/dL | Standard Deviation 25.84383 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 23.555 micrograms/dL | Standard Deviation 16.79989 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4.5 hrs | 46.99 micrograms/dL | Standard Deviation 33.692 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 8 hrs | 20.1875 micrograms/dL | Standard Deviation 19.10194 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 21.73286 micrograms/dL | Standard Deviation 19.95647 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 32.54286 micrograms/dL | Standard Deviation 32.58808 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | -23.0004 micrograms/dL | Standard Deviation 26.67792 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 10 hrs | -2.76 micrograms/dL | Standard Deviation 32.67052 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | -39.5 micrograms/dL | Standard Deviation 15.30849 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | -30.9866 micrograms/dL | Standard Deviation 23.72293 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | -31.966 micrograms/dL | Standard Deviation 22.61386 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 11.47783 micrograms/dL | Standard Deviation 44.51915 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | -38.3883 micrograms/dL | Standard Deviation 18.17201 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 40.34 micrograms/dL | Standard Deviation 14.2365 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 73.15 micrograms/dL | Standard Deviation 62.48 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -43.7666 micrograms/dL | Standard Deviation 28.14838 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 82.76 micrograms/dL | Standard Deviation 10.01489 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4.5 hrs | 94.38 micrograms/dL | Standard Deviation 12.827 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 14.625 micrograms/dL | Standard Deviation 13.54503 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 5 hrs | 88.88 micrograms/dL | Standard Deviation 30.95007 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | 11.7 micrograms/dL | Standard Deviation 33.80067 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 86.1 micrograms/dL | Standard Deviation 23.73584 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 7.5 hrs | 49.33333 micrograms/dL | Standard Deviation 35.15774 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 3 hrs | 77.64 micrograms/dL | Standard Deviation 25.54981 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -43.8 micrograms/dL | Standard Deviation 13.72461 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 8 hrs | 40.91667 micrograms/dL | Standard Deviation 32.76452 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 30.75 micrograms/dL | Standard Deviation 51.07636 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 22.075 micrograms/dL | Standard Deviation 15.44849 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | -5.89333 micrograms/dL | Standard Deviation 17.29701 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 118.6 micrograms/dL | Standard Deviation 40.09489 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 20.13333 micrograms/dL | Standard Deviation 9.256061 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -23.655 micrograms/dL | Standard Deviation 21.6553 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 88.28333 micrograms/dL | Standard Deviation 22.29039 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 33.21167 micrograms/dL | Standard Deviation 16.22149 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 7.5 hrs | 81.35 micrograms/dL | Standard Deviation 18.15717 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 44.21667 micrograms/dL | Standard Deviation 20.25452 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 10 hrs | 24.02833 micrograms/dL | Standard Deviation 19.2209 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 47.45 micrograms/dL | Standard Deviation 19.26954 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 143.4167 micrograms/dL | Standard Deviation 33.93585 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 21.82333 micrograms/dL | Standard Deviation 19.21886 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | -19.905 micrograms/dL | Standard Deviation 17.7931 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4.5 hrs | 150.8 micrograms/dL | Standard Deviation 39.0858 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 8 hrs | 60.02833 micrograms/dL | Standard Deviation 38.13224 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | 6.542 micrograms/dL | Standard Deviation 13.5174 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 3 hrs | 112.7333 micrograms/dL | Standard Deviation 29.95721 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | -22.5 micrograms/dL | Standard Deviation 13.67333 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | -10.3888 micrograms/dL | Standard Deviation 20.13357 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -9.72167 micrograms/dL | Standard Deviation 20.08234 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 5 hrs | 135.26 micrograms/dL | Standard Deviation 40.90584 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 5 hrs | 207.5 micrograms/dL | Standard Deviation 41.23469 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 67.24 micrograms/dL | Standard Deviation 29.08003 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 14.806 micrograms/dL | Standard Deviation 10.09701 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 41.53333 micrograms/dL | Standard Deviation 17.55844 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 119.34 micrograms/dL | Standard Deviation 46.55242 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 3 hrs | 173.4 micrograms/dL | Standard Deviation 17.38678 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 206 micrograms/dL | Standard Deviation 37.76242 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4.5 hrs | 196.25 micrograms/dL | Standard Deviation 46.29885 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 179.0833 micrograms/dL | Standard Deviation 40.56158 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 7.5 hrs | 131.45 micrograms/dL | Standard Deviation 31.91825 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 8 hrs | 118.25 micrograms/dL | Standard Deviation 38.3246 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 79.96 micrograms/dL | Standard Deviation 32.5411 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 10 hrs | 64.68333 micrograms/dL | Standard Deviation 37.53566 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | 23.21667 micrograms/dL | Standard Deviation 42.48879 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | 15.26667 micrograms/dL | Standard Deviation 27.3353 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | 0.895 micrograms/dL | Standard Deviation 27.98098 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | -12.35 micrograms/dL | Standard Deviation 31.50294 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -11.0612 micrograms/dL | Standard Deviation 15.55449 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | 2.05 micrograms/dL | Standard Deviation 15.61893 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -12.2612 micrograms/dL | Standard Deviation 17.42613 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 41.4 micrograms/dL | Standard Deviation 50.85712 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 95.21667 micrograms/dL | Standard Deviation 18.84658 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | -23.5 micrograms/dL | Standard Deviation 28.53482 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 8 hrs | 148 micrograms/dL | Standard Deviation 28.2772 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 7.5 hrs | 170.8333 micrograms/dL | Standard Deviation 27.63633 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 214.5 micrograms/dL | Standard Deviation 31.14322 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 58.65 micrograms/dL | Standard Deviation 21.0115 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 5 hrs | 238.1667 micrograms/dL | Standard Deviation 27.28675 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 31.73333 micrograms/dL | Standard Deviation 17.07579 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4.5 hrs | 258.3333 micrograms/dL | Standard Deviation 32.20973 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -35.55 micrograms/dL | Standard Deviation 22.41006 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | -11.655 micrograms/dL | Standard Deviation 20.10851 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 241.5 micrograms/dL | Standard Deviation 25.6963 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 3 hrs | 210 micrograms/dL | Standard Deviation 26.54807 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 150.3333 micrograms/dL | Standard Deviation 22.43806 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 48.46 micrograms/dL | Standard Deviation 18.48764 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | 28.13333 micrograms/dL | Standard Deviation 32.85319 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -27.3 micrograms/dL | Standard Deviation 15.28005 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | -6.56617 micrograms/dL | Standard Deviation 24.95741 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | 32.91667 micrograms/dL | Standard Deviation 22.9566 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 10 hrs | 81.01667 micrograms/dL | Standard Deviation 25.26099 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 122.6833 micrograms/dL | Standard Deviation 21.64813 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 25.4875 micrograms/dL | Standard Deviation 16.85459 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 7.5 hrs | 21.84125 micrograms/dL | Standard Deviation 16.90949 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 5 hrs | 47.8375 micrograms/dL | Standard Deviation 31.67153 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 15.81588 micrograms/dL | Standard Deviation 15.29313 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 26.3875 micrograms/dL | Standard Deviation 17.3591 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 39.7125 micrograms/dL | Standard Deviation 23.02839 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 24.04125 micrograms/dL | Standard Deviation 23.55888 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 16.12875 micrograms/dL | Standard Deviation 16.956 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4.5 hrs | 46.3125 micrograms/dL | Standard Deviation 26.86966 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | -29.4667 micrograms/dL | Standard Deviation 32.86135 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | -18.8714 micrograms/dL | Standard Deviation 17.95569 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 10 hrs | -5.4175 micrograms/dL | Standard Deviation 8.513109 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 8 hrs | 16.7375 micrograms/dL | Standard Deviation 14.66799 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | -25.4481 micrograms/dL | Standard Deviation 27.93334 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | 14.05 micrograms/dL | Standard Deviation 14.51925 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | -22.8429 micrograms/dL | Standard Deviation 22.18268 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 42.5375 micrograms/dL | Standard Deviation 27.70637 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 3.245 micrograms/dL | Standard Deviation 9.291451 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -20.7163 micrograms/dL | Standard Deviation 31.3054 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -15.6767 micrograms/dL | Standard Deviation 31.81849 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 3 hrs | 36.7375 micrograms/dL | Standard Deviation 24.39203 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 5 hrs | 105.95 micrograms/dL | Standard Deviation 21.48299 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 8 hrs | 50.58333 micrograms/dL | Standard Deviation 27.42418 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | 21.505 micrograms/dL | Standard Deviation 37.16592 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 30.23833 micrograms/dL | Standard Deviation 30.05141 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 10 hrs | 4.028333 micrograms/dL | Standard Deviation 21.84233 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | -35.8 micrograms/dL | Standard Deviation 16.87637 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -27.7 micrograms/dL | Standard Deviation 30.14558 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 26.68333 micrograms/dL | Standard Deviation 51.62024 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 27.45 micrograms/dL | Standard Deviation 10.6442 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 36.86667 micrograms/dL | Standard Deviation 8.992145 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 95.5 micrograms/dL | Standard Deviation 21.20547 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 51.73333 micrograms/dL | Standard Deviation 10.18797 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -39.8117 micrograms/dL | Standard Deviation 31.90823 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 69.25 micrograms/dL | Standard Deviation 11.37853 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | -33.9617 micrograms/dL | Standard Deviation 16.56204 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 3 hrs | 96.06667 micrograms/dL | Standard Deviation 17.22355 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 111.4167 micrograms/dL | Standard Deviation 21.85437 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4.5 hrs | 113 micrograms/dL | Standard Deviation 10.55936 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 7.5 hrs | 62.58333 micrograms/dL | Standard Deviation 27.26891 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | -22.0445 micrograms/dL | Standard Deviation 14.59163 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | -27.4617 micrograms/dL | Standard Deviation 12.8595 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 5 hrs | 171.3333 micrograms/dL | Standard Deviation 34.4248 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -16.6567 micrograms/dL | Standard Deviation 16.39093 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | -7.33333 micrograms/dL | Standard Deviation 19.53363 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 3 hrs | 1148.3333 micrograms/dL | Standard Deviation 26.3717 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 179.1667 micrograms/dL | Standard Deviation 35.79618 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -24.7233 micrograms/dL | Standard Deviation 22.46531 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 8 hrs | 84.1 micrograms/dL | Standard Deviation 23.7459 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | 0.116667 micrograms/dL | Standard Deviation 16.23887 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 10 hrs | 25.38333 micrograms/dL | Standard Deviation 18.08142 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 35.36667 micrograms/dL | Standard Deviation 12.16251 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 52.21667 micrograms/dL | Standard Deviation 17.32494 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 46.41667 micrograms/dL | Standard Deviation 11.35067 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | -23.4283 micrograms/dL | Standard Deviation 26.12766 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4.5 hrs | 183.5 micrograms/dL | Standard Deviation 37.35639 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 70.8 micrograms/dL | Standard Deviation 14.34489 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | -10.2667 micrograms/dL | Standard Deviation 22.21894 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | -14.85 micrograms/dL | Standard Deviation 28.31902 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 24.76667 micrograms/dL | Standard Deviation 12.58438 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 149 micrograms/dL | Standard Deviation 31.89357 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 112.55 micrograms/dL | Standard Deviation 17.88449 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 7.5 hrs | 95.25 micrograms/dL | Standard Deviation 18.04658 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 18.03333 micrograms/dL | Standard Deviation 13.6192 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4.5 hrs | 230.5 micrograms/dL | Standard Deviation 54.47844 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 7.5 hrs | 158.2667 micrograms/dL | Standard Deviation 63.67312 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | 3.167167 micrograms/dL | Standard Deviation 13.43837 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 40.945 micrograms/dL | Standard Deviation 32.03071 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 48.3 micrograms/dL | Standard Deviation 16.06275 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 81.31667 micrograms/dL | Standard Deviation 21.66614 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 142.9 micrograms/dL | Standard Deviation 27.52417 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 3 hrs | 194.3333 micrograms/dL | Standard Deviation 39.70222 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 229.8333 micrograms/dL | Standard Deviation 58.21483 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 5 hrs | 240.6667 micrograms/dL | Standard Deviation 42.41541 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 188.95 micrograms/dL | Standard Deviation 53.37429 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 8 hrs | 125.1 micrograms/dL | Standard Deviation 50.25754 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 104.1883 micrograms/dL | Standard Deviation 51.15559 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 10 hrs | 67.95 micrograms/dL | Standard Deviation 42.27547 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | 28.65 micrograms/dL | Standard Deviation 22.83486 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | 15.68333 micrograms/dL | Standard Deviation 19.74056 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | -12.0333 micrograms/dL | Standard Deviation 33.63212 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -18.1717 micrograms/dL | Standard Deviation 16.19425 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | 7.605 micrograms/dL | Standard Deviation 22.55452 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -11.74 micrograms/dL | Standard Deviation 14.89775 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 222.8333 micrograms/dL | Standard Deviation 26.60388 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | 24.82833 micrograms/dL | Standard Deviation 38.29261 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 247.8333 micrograms/dL | Standard Deviation 28.47045 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 166.6667 micrograms/dL | Standard Deviation 22.00606 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 102.8 micrograms/dL | Standard Deviation 22.60044 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 62.93333 micrograms/dL | Standard Deviation 20.16231 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 34.47833 micrograms/dL | Standard Deviation 22.29513 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 42.94 micrograms/dL | Standard Deviation 12.77861 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | -28.2167 micrograms/dL | Standard Deviation 30.50996 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | -16.455 micrograms/dL | Standard Deviation 21.98194 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -40.4883 micrograms/dL | Standard Deviation 27.31494 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -37.3 micrograms/dL | Standard Deviation 14.24949 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | -6.195 micrograms/dL | Standard Deviation 29.40307 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | 32.745 micrograms/dL | Standard Deviation 29.99864 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 7.5 hrs | 175.8333 micrograms/dL | Standard Deviation 27.83822 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 10 hrs | 87.16667 micrograms/dL | Standard Deviation 31.49366 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 125.35 micrograms/dL | Standard Deviation 23.78098 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 3 hrs | 223.6667 micrograms/dL | Standard Deviation 21.58394 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 8 hrs | 154.1667 micrograms/dL | Standard Deviation 30.0494 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 5 hrs | 241.8333 micrograms/dL | Standard Deviation 21.80291 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4.5 hrs | 259.1667 micrograms/dL | Standard Deviation 36.66833 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | 11.8 micrograms/dL | Standard Deviation 19.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 7.5 hrs | -25.1 micrograms/dL | Standard Deviation 35.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4.5 hrs | -37.9 micrograms/dL | Standard Deviation 33.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 28.1 micrograms/dL | Standard Deviation 28.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -34.5 micrograms/dL | Standard Deviation 29.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 5 hrs | -39.9 micrograms/dL | Standard Deviation 37.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -12.2 micrograms/dL | Standard Deviation 25.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | 16 micrograms/dL | Standard Deviation 8.71 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -15.7 micrograms/dL | Standard Deviation 16.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | 21 micrograms/dL | Standard Deviation 24.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | 17.1 micrograms/dL | Standard Deviation 10.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -22.4 micrograms/dL | Standard Deviation 19.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | 19.4 micrograms/dL | Standard Deviation 10.5 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -29.1 micrograms/dL | Standard Deviation 34.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 10 hrs | 7 micrograms/dL | Standard Deviation 12 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -30.3 micrograms/dL | Standard Deviation 24.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -5.54 micrograms/dL | Standard Deviation 23.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 3 hrs | -38.9 micrograms/dL | Standard Deviation 26.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | -9.1 micrograms/dL | Standard Deviation 13.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 8 hrs | -8.54 micrograms/dL | Standard Deviation 15.5 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -44.8 micrograms/dL | Standard Deviation 31.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | -24.7 micrograms/dL | Standard Deviation 32.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 7.5 hrs | -61.8 micrograms/dL | Standard Deviation 28.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -41.5 micrograms/dL | Standard Deviation 7.97 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | 22.5 micrograms/dL | Standard Deviation 21.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4.5 hrs | -103 micrograms/dL | Standard Deviation 10.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -23.6 micrograms/dL | Standard Deviation 22.9 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -97.3 micrograms/dL | Standard Deviation 25.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -117 micrograms/dL | Standard Deviation 22.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -51.1 micrograms/dL | Standard Deviation 9.91 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 5 hrs | -105 micrograms/dL | Standard Deviation 25.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | 11.9 micrograms/dL | Standard Deviation 28.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 41.1 micrograms/dL | Standard Deviation 30.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -23.4 micrograms/dL | Standard Deviation 46.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | 32.8 micrograms/dL | Standard Deviation 11.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 10 hrs | -3.71 micrograms/dL | Standard Deviation 18.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | 26 micrograms/dL | Standard Deviation 13.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 8 hrs | -48.9 micrograms/dL | Standard Deviation 26.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -27 micrograms/dL | Standard Deviation 9.55 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 3 hrs | -100 micrograms/dL | Standard Deviation 21.4 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -74.1 micrograms/dL | Standard Deviation 10.9 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | 24.4 micrograms/dL | Standard Deviation 13.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -21.1 micrograms/dL | Standard Deviation 16 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | 18.5 micrograms/dL | Standard Deviation 30.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | 19 micrograms/dL | Standard Deviation 25.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -22.9 micrograms/dL | Standard Deviation 10.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -50.2 micrograms/dL | Standard Deviation 10.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -68.7 micrograms/dL | Standard Deviation 10.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -115 micrograms/dL | Standard Deviation 22.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 3 hrs | -152 micrograms/dL | Standard Deviation 26.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -182 micrograms/dL | Standard Deviation 36.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4.5 hrs | -175 micrograms/dL | Standard Deviation 34.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 5 hrs | -166 micrograms/dL | Standard Deviation 35.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -143 micrograms/dL | Standard Deviation 31.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 7.5 hrs | -95.3 micrograms/dL | Standard Deviation 26.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 8 hrs | -77.4 micrograms/dL | Standard Deviation 26.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -46.5 micrograms/dL | Standard Deviation 25.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 10 hrs | -20 micrograms/dL | Standard Deviation 23.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | 8.56 micrograms/dL | Standard Deviation 26.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | 14 micrograms/dL | Standard Deviation 32 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | 17.7 micrograms/dL | Standard Deviation 37.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | 13.8 micrograms/dL | Standard Deviation 22.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 28.6 micrograms/dL | Standard Deviation 19.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 7.5 hrs | -156 micrograms/dL | Standard Deviation 68.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 3 hrs | -201 micrograms/dL | Standard Deviation 39.2 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 23.1 micrograms/dL | Standard Deviation 15.1 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 8 hrs | -121 micrograms/dL | Standard Deviation 52.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -148 micrograms/dL | Standard Deviation 25.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | 1.57 micrograms/dL | Standard Deviation 23 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -106 micrograms/dL | Standard Deviation 56.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -85.9 micrograms/dL | Standard Deviation 19.2 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 10 hrs | -65.7 micrograms/dL | Standard Deviation 50.1 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -56.8 micrograms/dL | Standard Deviation 17.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | -21.5 micrograms/dL | Standard Deviation 33.7 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -17.9 micrograms/dL | Standard Deviation 13.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | -16.7 micrograms/dL | Standard Deviation 33.7 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -23.8 micrograms/dL | Standard Deviation 38.3 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | 0.667 micrograms/dL | Standard Deviation 20 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | 15.3 micrograms/dL | Standard Deviation 15.5 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 5 hrs | -237 micrograms/dL | Standard Deviation 60.6 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4.5 hrs | -222 micrograms/dL | Standard Deviation 59.4 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -185 micrograms/dL | Standard Deviation 50.9 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -242 micrograms/dL | Standard Deviation 58.8 |
| Cohort 3 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | 10.8 micrograms/dL | Standard Deviation 10.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -246 micrograms/dL | Standard Deviation 29.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 7.5 hrs | -183 micrograms/dL | Standard Deviation 32.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 3 hrs | -229 micrograms/dL | Standard Deviation 30.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -44.4 micrograms/dL | Standard Deviation 18.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 8 hrs | -161 micrograms/dL | Standard Deviation 34.8 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 5 hrs | -239 micrograms/dL | Standard Deviation 30.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -179 micrograms/dL | Standard Deviation 25.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | -30.6 micrograms/dL | Standard Deviation 34.4 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4.5 hrs | -243 micrograms/dL | Standard Deviation 30.8 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -70.7 micrograms/dL | Standard Deviation 23.8 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -132 micrograms/dL | Standard Deviation 29.7 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -106 micrograms/dL | Standard Deviation 22.6 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 38.7 micrograms/dL | Standard Deviation 21.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | 14 micrograms/dL | Standard Deviation 16.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -228 micrograms/dL | Standard Deviation 33.5 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 10 hrs | -95.5 micrograms/dL | Standard Deviation 34.9 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | 16.5 micrograms/dL | Standard Deviation 33.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -37.4 micrograms/dL | Standard Deviation 24 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | -5.4 micrograms/dL | Standard Deviation 34.1 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | 23.1 micrograms/dL | Standard Deviation 26.3 |
| Cohort 6 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | -43.7 micrograms/dL | Standard Deviation 32 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | 0.0167 micrograms/dL | Standard Deviation 1.39 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 30 hrs | -3.68 micrograms/dL | Standard Deviation 3.09 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | -10.4 micrograms/dL | Standard Deviation 7.52 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | -1.63 micrograms/dL | Standard Deviation 1.54 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | 4.9 micrograms/dL | Standard Deviation 9.01 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 18 hrs | -0.767 micrograms/dL | Standard Deviation 9.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -7.44 micrograms/dL | Standard Deviation 8.71 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -10.8 micrograms/dL | Standard Deviation 12.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -4.63 micrograms/dL | Standard Deviation 1.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -6.63 micrograms/dL | Standard Deviation 4.35 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | -8.63 micrograms/dL | Standard Deviation 8.31 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | -4.6 micrograms/dL | Standard Deviation 14.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -4.08 micrograms/dL | Standard Deviation 2.22 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | -6.53 micrograms/dL | Standard Deviation 13.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | -6.97 micrograms/dL | Standard Deviation 13.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -6.57 micrograms/dL | Standard Deviation 4.26 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | 3.17 micrograms/dL | Standard Deviation 2.29 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -5.93 micrograms/dL | Standard Deviation 8.93 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | 1.83 micrograms/dL | Standard Deviation 16.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | -16.3 micrograms/dL | Standard Deviation 15.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | -3.38 micrograms/dL | Standard Deviation 7.01 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -5.95 micrograms/dL | Standard Deviation 7.54 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | -6.93 micrograms/dL | Standard Deviation 9.07 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 30 hrs | 1.22 micrograms/dL | Standard Deviation 9.34 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 18 hrs | 1.81 micrograms/dL | Standard Deviation 8.29 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | 2.75 micrograms/dL | Standard Deviation 8.15 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | -11.7 micrograms/dL | Standard Deviation 12.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | -12.9 micrograms/dL | Standard Deviation 23.4 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -10.1 micrograms/dL | Standard Deviation 8.65 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | 5.32 micrograms/dL | Standard Deviation 20.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -4.03 micrograms/dL | Standard Deviation 22.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -15.8 micrograms/dL | Standard Deviation 16.4 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | -10.1 micrograms/dL | Standard Deviation 18.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -1.58 micrograms/dL | Standard Deviation 2.45 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 20 hrs | -14.4 micrograms/dL | Standard Deviation 31 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 24 hrs | -10.8 micrograms/dL | Standard Deviation 27.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 30 hrs | -2.87 micrograms/dL | Standard Deviation 35.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 36 hrs | -6.44 micrograms/dL | Standard Deviation 29.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0 hrs | -13.9 micrograms/dL | Standard Deviation 25.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 0.5 hrs | -14.8 micrograms/dL | Standard Deviation 26.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 1 hr | -9.99 micrograms/dL | Standard Deviation 38.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 2 hrs | -20.7 micrograms/dL | Standard Deviation 28.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 4 hrs | -17.6 micrograms/dL | Standard Deviation 28.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 48 hrs | -8.46 micrograms/dL | Standard Deviation 36.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 6 hrs | -18.1 micrograms/dL | Standard Deviation 28.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 9 hrs | -19.8 micrograms/dL | Standard Deviation 28.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12 hrs | -18.4 micrograms/dL | Standard Deviation 22.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 12.5 hrs | -20.2 micrograms/dL | Standard Deviation 28.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 14 hrs | -14.2 micrograms/dL | Standard Deviation 33.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 16 hrs | -17.9 micrograms/dL | Standard Deviation 29.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) | t = 18 hrs | -8.14 micrograms/dL | Standard Deviation 28 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 18 hrs | 342 micrograms/dL | Standard Deviation 13.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 330 micrograms/dL | Standard Deviation 19.5 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 352 micrograms/dL | Standard Deviation 20.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 337 micrograms/dL | Standard Deviation 18.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 337 micrograms/dL | Standard Deviation 17.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 346 micrograms/dL | Standard Deviation 33.7 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 346 micrograms/dL | Standard Deviation 31.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 333 micrograms/dL | Standard Deviation 20.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 30 hrs | 344 micrograms/dL | Standard Deviation 28.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 334 micrograms/dL | Standard Deviation 22.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 340 micrograms/dL | Standard Deviation 15.9 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 339 micrograms/dL | Standard Deviation 19.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 338 micrograms/dL | Standard Deviation 19.1 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 332 micrograms/dL | Standard Deviation 18.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 338 micrograms/dL | Standard Deviation 21.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 334 micrograms/dL | Standard Deviation 33.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 345 micrograms/dL | Standard Deviation 22.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 328 micrograms/dL | Standard Deviation 41.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 324 micrograms/dL | Standard Deviation 37.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 319 micrograms/dL | Standard Deviation 40.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 325 micrograms/dL | Standard Deviation 37.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 338 micrograms/dL | Standard Deviation 40.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 340 micrograms/dL | Standard Deviation 37.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 18 hrs | 337 micrograms/dL | Standard Deviation 40.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 329 micrograms/dL | Standard Deviation 40.4 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 344 micrograms/dL | Standard Deviation 43.3 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 30 hrs | 339 micrograms/dL | Standard Deviation 42.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 344 micrograms/dL | Standard Deviation 46.4 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 337 micrograms/dL | Standard Deviation 42.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 346 micrograms/dL | Standard Deviation 49.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 328 micrograms/dL | Standard Deviation 41.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 338 micrograms/dL | Standard Deviation 42 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 336 micrograms/dL | Standard Deviation 43.8 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 336 micrograms/dL | Standard Deviation 42.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 48 hrs | 343 micrograms/dL | Standard Deviation 38.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 16 hrs | 325 micrograms/dL | Standard Deviation 32.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 2 hrs | 335 micrograms/dL | Standard Deviation 36.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 0 hrs | 340 micrograms/dL | Standard Deviation 41.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 14 hrs | 325 micrograms/dL | Standard Deviation 31.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 9 hrs | 318 micrograms/dL | Standard Deviation 37.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 0.5 hrs | 328 micrograms/dL | Standard Deviation 36.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 12.5 hrs | 323 micrograms/dL | Standard Deviation 35.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 6 hrs | 317 micrograms/dL | Standard Deviation 41.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 24 hrs | 342 micrograms/dL | Standard Deviation 39.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 1 hr | 336 micrograms/dL | Standard Deviation 40.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 30 hrs | 350 micrograms/dL | Standard Deviation 35.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 20 hrs | 325 micrograms/dL | Standard Deviation 39 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 12 hrs | 308 micrograms/dL | Standard Deviation 35.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 36 hrs | 345 micrograms/dL | Standard Deviation 35.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 18 hrs | 330 micrograms/dL | Standard Deviation 34.3 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) | t = 4 hrs | 335 micrograms/dL | Standard Deviation 43.7 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 24.9325 micrograms/dL | Standard Deviation 17.2084 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 30 hrs | 31.485 micrograms/dL | Standard Deviation 48.38732 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | -2.9 micrograms/dL | Standard Deviation 24.60732 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 41.16667 micrograms/dL | Standard Deviation 32.85869 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 34.03333 micrograms/dL | Standard Deviation 13.70632 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | -5.53333 micrograms/dL | Standard Deviation 28.14255 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 42.975 micrograms/dL | Standard Deviation 36.03807 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | 2.175 micrograms/dL | Standard Deviation 29.20575 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 17.6 micrograms/dL | Standard Deviation 41.26835 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | -19.1667 micrograms/dL | Standard Deviation 15.64811 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | 21.62233 micrograms/dL | Standard Deviation 19.48729 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 21.7 micrograms/dL | Standard Deviation 13.11602 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 22.575 micrograms/dL | Standard Deviation 8.144272 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -5.2889 micrograms/dL | Standard Deviation 7.137707 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 23 micrograms/dL | Standard Deviation 11.37629 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -0.52333 micrograms/dL | Standard Deviation 21.42192 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 18 hrs | -12.3 micrograms/dL | Standard Deviation 13.66711 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 26.25 micrograms/dL | Standard Deviation 13.70631 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 15.55 micrograms/dL | Standard Deviation 11.59451 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 168.8 micrograms/dL | Standard Deviation 35.75891 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 30 hrs | -30.225 micrograms/dL | Standard Deviation 27.25856 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -23.15 micrograms/dL | Standard Deviation 40.39885 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 36.02 micrograms/dL | Standard Deviation 26.44139 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 49.46667 micrograms/dL | Standard Deviation 12.52576 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 77.62 micrograms/dL | Standard Deviation 17.82826 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 140.2 micrograms/dL | Standard Deviation 19.84187 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 167.2 micrograms/dL | Standard Deviation 42.3757 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | 176 micrograms/dL | Standard Deviation 43.28972 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | 141.3833 micrograms/dL | Standard Deviation 49.73572 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | 116.7 micrograms/dL | Standard Deviation 47.4452 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | 38.18 micrograms/dL | Standard Deviation 30.55899 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 18 hrs | 25.84 micrograms/dL | Standard Deviation 37.53582 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -6.06667 micrograms/dL | Standard Deviation 31.71553 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | -10.2333 micrograms/dL | Standard Deviation 35.97225 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 2 hrs | 107.6333 micrograms/dL | Standard Deviation 43.33413 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 48 hrs | 19.95 micrograms/dL | Standard Deviation 39.70616 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 14 hrs | 161.9667 micrograms/dL | Standard Deviation 46.50513 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 24 hrs | -20.0617 micrograms/dL | Standard Deviation 26.62087 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 16 hrs | 92.43833 micrograms/dL | Standard Deviation 56.28477 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 1 hr | 68.23333 micrograms/dL | Standard Deviation 44.6479 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 30 hrs | -25.6333 micrograms/dL | Standard Deviation 29.99492 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 18 hrs | 47.605 micrograms/dL | Standard Deviation 37.80162 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 0.5 hrs | 29.97167 micrograms/dL | Standard Deviation 33.57264 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 36 hrs | -34.6333 micrograms/dL | Standard Deviation 41.33162 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 9 hrs | 228.8333 micrograms/dL | Standard Deviation 44.96851 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 6 hrs | 232 micrograms/dL | Standard Deviation 48.90808 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 20 hrs | -3.09 micrograms/dL | Standard Deviation 29.31886 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 12 hrs | 214.5 micrograms/dL | Standard Deviation 49.31835 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 4 hrs | 197.6667 micrograms/dL | Standard Deviation 46.28031 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 0 hrs | 7.888333 micrograms/dL | Standard Deviation 33.94121 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) | t = 12.5 hrs | 208.1667 micrograms/dL | Standard Deviation 51.0232 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 31.35 micrograms/dL | Standard Deviation 14.11772 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | -0.975 micrograms/dL | Standard Deviation 28.42761 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 35.75 micrograms/dL | Standard Deviation 16.21532 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 50.9 micrograms/dL | Standard Deviation 26.83927 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 40.46667 micrograms/dL | Standard Deviation 15.25036 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 24.285 micrograms/dL | Standard Deviation 43.9688 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 55 micrograms/dL | Standard Deviation 38.45179 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -5.4 micrograms/dL | Standard Deviation 27.97803 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 18 hrs | -11.52 micrograms/dL | Standard Deviation 11.5913 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | -12.1867 micrograms/dL | Standard Deviation 10.43401 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | 30.39 micrograms/dL | Standard Deviation 23.14673 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 30 hrs | 26.44667 micrograms/dL | Standard Deviation 41.6933 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | -7.03333 micrograms/dL | Standard Deviation 19.74369 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 26.675 micrograms/dL | Standard Deviation 10.10095 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 24.6 micrograms/dL | Standard Deviation 12.80989 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -0.67667 micrograms/dL | Standard Deviation 20.99592 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | -3.86667 micrograms/dL | Standard Deviation 28.73436 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 17.13333 micrograms/dL | Standard Deviation 13.10836 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 56.01667 micrograms/dL | Standard Deviation 12.43309 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 93.36667 micrograms/dL | Standard Deviation 16.01058 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | 157.6667 micrograms/dL | Standard Deviation 47.00496 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | 117.3333 micrograms/dL | Standard Deviation 45.18808 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 32.36667 micrograms/dL | Standard Deviation 14.44322 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 152 micrograms/dL | Standard Deviation 14.02854 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 186.8 micrograms/dL | Standard Deviation 27.12379 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 181.3333 micrograms/dL | Standard Deviation 34.92659 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | 178.5 micrograms/dL | Standard Deviation 47.26415 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | 57.75 micrograms/dL | Standard Deviation 41.30815 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 18 hrs | 17.705 micrograms/dL | Standard Deviation 33.84819 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | -8.81667 micrograms/dL | Standard Deviation 25.93025 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | -12.0567 micrograms/dL | Standard Deviation 25.6596 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 30 hrs | -18.8283 micrograms/dL | Standard Deviation 30.65685 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -28.1672 micrograms/dL | Standard Deviation 32.82391 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 41.026 micrograms/dL | Standard Deviation 34.08901 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0 hrs | 22.31167 micrograms/dL | Standard Deviation 25.13075 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 16 hrs | 114.3117 micrograms/dL | Standard Deviation 73.84014 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 14 hrs | 180.65 micrograms/dL | Standard Deviation 69.86598 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 2 hrs | 136.3333 micrograms/dL | Standard Deviation 27.94041 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 18 hrs | 58.51667 micrograms/dL | Standard Deviation 63.66288 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12 hrs | 236.8333 micrograms/dL | Standard Deviation 62.58887 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 48 hrs | 30.78333 micrograms/dL | Standard Deviation 48.96756 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 20 hrs | 12.61167 micrograms/dL | Standard Deviation 53.50657 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 6 hrs | 255.5 micrograms/dL | Standard Deviation 51.20059 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 4 hrs | 222.5 micrograms/dL | Standard Deviation 41.28801 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 36 hrs | -28.35 micrograms/dL | Standard Deviation 35.19118 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 9 hrs | 254.5 micrograms/dL | Standard Deviation 60.24201 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 1 hr | 80.48333 micrograms/dL | Standard Deviation 26.35234 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 24 hrs | -9.53833 micrograms/dL | Standard Deviation 41.94388 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 0.5 hrs | 46.76667 micrograms/dL | Standard Deviation 25.7235 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 12.5 hrs | 237.8333 micrograms/dL | Standard Deviation 68.42051 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) | t = 30 hrs | -22.9778 micrograms/dL | Standard Deviation 23.78139 |
Primary
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -19.7 micrograms/dL | Standard Deviation 8.82 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | -22.8 micrograms/dL | Standard Deviation 33.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -58.7 micrograms/dL | Standard Deviation 41.6 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | -1.21 micrograms/dL | Standard Deviation 29.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -26.2 micrograms/dL | Standard Deviation 25.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 13.7 micrograms/dL | Standard Deviation 39.4 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | -3.59 micrograms/dL | Standard Deviation 30.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -29.7 micrograms/dL | Standard Deviation 16.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | -0.0778 micrograms/dL | Standard Deviation 30.5 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -51.2 micrograms/dL | Standard Deviation 25.8 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -37.1 micrograms/dL | Standard Deviation 19.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -32.4 micrograms/dL | Standard Deviation 46.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 30 hrs | -20.9 micrograms/dL | Standard Deviation 53.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | 8.29 micrograms/dL | Standard Deviation 17.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 18 hrs | 15.4 micrograms/dL | Standard Deviation 20.3 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | 11.8 micrograms/dL | Standard Deviation 11.2 |
| Cohorts 1 - 3, 6 Placebo | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -30.4 micrograms/dL | Standard Deviation 11.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | -131 micrograms/dL | Standard Deviation 52.9 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -12.4 micrograms/dL | Standard Deviation 17.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -46.5 micrograms/dL | Standard Deviation 9.79 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -158 micrograms/dL | Standard Deviation 21.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -189 micrograms/dL | Standard Deviation 38.5 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -199 micrograms/dL | Standard Deviation 41.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | -59.7 micrograms/dL | Standard Deviation 58.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | 14.6 micrograms/dL | Standard Deviation 24.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 30.1 micrograms/dL | Standard Deviation 37.7 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -35.8 micrograms/dL | Standard Deviation 36.2 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -59.8 micrograms/dL | Standard Deviation 8.85 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -99.2 micrograms/dL | Standard Deviation 14 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | -201 micrograms/dL | Standard Deviation 51.9 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | -174 micrograms/dL | Standard Deviation 66.1 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 18 hrs | -22.3 micrograms/dL | Standard Deviation 44.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | -3.63 micrograms/dL | Standard Deviation 33.6 |
| Cohort 1 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 30 hrs | 15.9 micrograms/dL | Standard Deviation 35.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12 hrs | -241 micrograms/dL | Standard Deviation 51.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 36 hrs | 36.6 micrograms/dL | Standard Deviation 34.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0.5 hrs | -56.3 micrograms/dL | Standard Deviation 29.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 12.5 hrs | -236 micrograms/dL | Standard Deviation 60.7 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 16 hrs | -126 micrograms/dL | Standard Deviation 76.4 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 14 hrs | -193 micrograms/dL | Standard Deviation 76.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 0 hrs | -19.4 micrograms/dL | Standard Deviation 29.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 18 hrs | -65.7 micrograms/dL | Standard Deviation 65.6 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 6 hrs | -247 micrograms/dL | Standard Deviation 37.5 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 30 hrs | 35.8 micrograms/dL | Standard Deviation 28.1 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 20 hrs | -24.7 micrograms/dL | Standard Deviation 52.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 4 hrs | -216 micrograms/dL | Standard Deviation 27.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 2 hrs | -138 micrograms/dL | Standard Deviation 32.9 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 1 hr | -81.3 micrograms/dL | Standard Deviation 29.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 9 hrs | -246 micrograms/dL | Standard Deviation 44.2 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 48 hrs | -24.5 micrograms/dL | Standard Deviation 54.8 |
| Cohort 2 SFP | Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) | t = 24 hrs | 14.3 micrograms/dL | Standard Deviation 49.4 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 62.6 microgram/dL | Standard Deviation 32.4 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 44.3 microgram/dL | Standard Deviation 34.8 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 113 microgram/dL | Standard Deviation 44.5 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 151 microgram/dL | Standard Deviation 33.9 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 228 microgram/dL | Standard Deviation 19.7 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 177 microgram/dL | Standard Deviation 38.2 |
| Cohort 5 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 251 microgram/dL | Standard Deviation 51.7 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 261 microgram/dL | Standard Deviation 30.3 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 289 h*microgram/dL | Standard Deviation 235 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 126 h*microgram/dL | Standard Deviation 103 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 340 h*microgram/dL | Standard Deviation 206 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 277 h*microgram/dL | Standard Deviation 409 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 107 h*microgram/dL | Standard Deviation 68.8 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 334 h*microgram/dL | Standard Deviation 412 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 546 h*microgram/dL | Standard Deviation 312 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 579 h*microgram/dL | Standard Deviation 265 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 235 h*microgram/dL | Standard Deviation 104 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 903 h*microgram/dL | Standard Deviation 261 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 890 h*microgram/dL | Standard Deviation 258 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 329 h*microgram/dL | Standard Deviation 84.8 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 1460 h*microgram/dL | Standard Deviation 340 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 471 h*microgram/dL | Standard Deviation 97.7 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 1420 h*microgram/dL | Standard Deviation 316 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 2070 h*microgram/dL | Standard Deviation 639 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 1590 h*microgram/dL | Standard Deviation 336 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 305 h*microgram/dL | Standard Deviation 56 |
| Cohort 5 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 3000 h*microgram/dL | Standard Deviation 677 |
| Cohort 5 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 426 h*microgram/dL | Standard Deviation 151 |
| Cohort 5 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 2210 h*microgram/dL | Standard Deviation 402 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 4 | 590 h*microgram/dL | Standard Deviation 76.7 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC last | 1820 h*microgram/dL | Standard Deviation 263 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) | AUC 0 - 12 | 1770 h*microgram/dL | Standard Deviation 222 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 675 h*microgram/dL | Standard Deviation 270 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 1010 h*microgram/dL | Standard Deviation 190 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 1650 h*microgram/dL | Standard Deviation 172 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 2340 h*microgram/dL | Standard Deviation 565 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 3150 h*microgram/dL | Standard Deviation 657 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 1840 h*microgram/dL | Standard Deviation 263 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 4.06 dL/hour | Standard Deviation 1.2 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 5.11 dL/hour | Standard Deviation 0.99 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 4.59 dL/hour | Standard Deviation 0.464 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 6.72 dL/hour | Standard Deviation 1.63 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 6.61 dL/hour | Standard Deviation 1.5 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 5.56 dL/hour | Standard Deviation 0.938 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 45.3 micrograms/dL/mg | Standard Deviation 17.8 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 30.2 micrograms/dL/mg | Standard Deviation 6.78 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 30.4 micrograms/dL/mg | Standard Deviation 2.63 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 11.8 micrograms/dL/mg | Standard Deviation 2.55 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 12.5 micrograms/dL/mg | Standard Deviation 2.59 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 26.1 micrograms/dL/mg | Standard Deviation 3.03 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 1.3 hours | Standard Deviation 0.187 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 1.19 hours | Standard Deviation 0.476 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 1.29 hours | Standard Deviation 0.721 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 1.87 hours | Standard Deviation 1.08 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 2.21 hours | Standard Deviation 0.549 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 1.04 hours | Standard Deviation 0.505 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.544 1/hour | Standard Deviation 0.0788 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.668 1/hour | Standard Deviation 0.281 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.711 1/hour | Standard Deviation 0.423 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.475 1/hour | Standard Deviation 0.262 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.337 1/hour | Standard Deviation 0.114 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.917 1/hour | Standard Deviation 0.688 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 7.65 dL | Standard Deviation 2.84 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 8.43 dL | Standard Deviation 2.94 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 8.59 dL | Standard Deviation 4.79 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 16.6 dL | Standard Deviation 6.33 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 20.8 dL | Standard Deviation 6.8 |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 8.33 dL | Standard Deviation 4.05 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 4.5 hours |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 6 hours |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 4.5 hours |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 4.5 hours |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 4.75 hours |
| Cohort 4 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 7.5 hours |
| Cohort 5 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 6 hours |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 4.5 hours |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 29.5625 percentage of saturation | Standard Deviation 21.098337 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 15.968571 percentage of saturation | Standard Deviation 9.7540546 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 26.375 percentage of saturation | Standard Deviation 19.6707 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 10 hrs | 19.4325 percentage of saturation | Standard Deviation 13.439108 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4.5 hrs | 34.1 percentage of saturation | Standard Deviation 21.703917 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 27.55 percentage of saturation | Standard Deviation 15.727683 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 16.454286 percentage of saturation | Standard Deviation 5.1594536 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 29.4125 percentage of saturation | Standard Deviation 23.073141 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 7.5 hrs | 29.375 percentage of saturation | Standard Deviation 24.115659 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 13.305714 percentage of saturation | Standard Deviation 3.6857693 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 33.9625 percentage of saturation | Standard Deviation 22.445867 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 3 hrs | 32.1875 percentage of saturation | Standard Deviation 21.176904 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 15.332857 percentage of saturation | Standard Deviation 7.8527208 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 14.835 percentage of saturation | Standard Deviation 4.4686303 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 32.75 percentage of saturation | Standard Deviation 21.835816 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 25.70875 percentage of saturation | Standard Deviation 18.521548 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 8 hrs | 25.38625 percentage of saturation | Standard Deviation 17.277825 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 23.18875 percentage of saturation | Standard Deviation 18.870984 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 5 hrs | 34.825 percentage of saturation | Standard Deviation 24.362251 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 16.518571 percentage of saturation | Standard Deviation 9.4347451 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 24.4125 percentage of saturation | Standard Deviation 10.022038 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 5 hrs | 66.8 percentage of saturation | Standard Deviation 16.702934 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 25.916667 percentage of saturation | Standard Deviation 9.637306 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 23.366667 percentage of saturation | Standard Deviation 10.372592 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 24.566667 percentage of saturation | Standard Deviation 8.6832406 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 22.483333 percentage of saturation | Standard Deviation 8.5307483 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 41.866667 percentage of saturation | Standard Deviation 14.993421 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 41.85 percentage of saturation | Standard Deviation 12.577559 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 19.883333 percentage of saturation | Standard Deviation 5.2162886 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 45.583333 percentage of saturation | Standard Deviation 12.795533 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 40.533333 percentage of saturation | Standard Deviation 14.972864 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 49.533333 percentage of saturation | Standard Deviation 13.224019 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 56.15 percentage of saturation | Standard Deviation 13.052624 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 3 hrs | 64.666667 percentage of saturation | Standard Deviation 16.043898 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 69.883333 percentage of saturation | Standard Deviation 16.560002 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 40 percentage of saturation | Standard Deviation 8.7824826 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 64 percentage of saturation | Standard Deviation 16.355427 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4.5 hrs | 64.6 percentage of saturation | Standard Deviation 12.73185 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 7.5 hrs | 53.083333 percentage of saturation | Standard Deviation 16.412973 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 8 hrs | 49.183333 percentage of saturation | Standard Deviation 15.874182 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 25.916667 percentage of saturation | Standard Deviation 10.491981 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 10 hrs | 34.466667 percentage of saturation | Standard Deviation 13.005794 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 5 hrs | 70.983333 percentage of saturation | Standard Deviation 19.212227 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 27.466667 percentage of saturation | Standard Deviation 13.091626 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 15.301667 percentage of saturation | Standard Deviation 8.8581091 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 35.533333 percentage of saturation | Standard Deviation 15.038972 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 64.116667 percentage of saturation | Standard Deviation 18.901896 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 29.383333 percentage of saturation | Standard Deviation 11.362291 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 14.198333 percentage of saturation | Standard Deviation 6.6138655 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 17.828333 percentage of saturation | Standard Deviation 11.615611 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 7.5 hrs | 49.316667 percentage of saturation | Standard Deviation 16.104089 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4.5 hrs | 74.25 percentage of saturation | Standard Deviation 20.471614 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 12.386667 percentage of saturation | Standard Deviation 4.4342606 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 12.835 percentage of saturation | Standard Deviation 6.5323617 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 3 hrs | 65.866667 percentage of saturation | Standard Deviation 17.335128 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 8 hrs | 44.9 percentage of saturation | Standard Deviation 17.190579 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 19 percentage of saturation | Standard Deviation 5.8845561 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 54.75 percentage of saturation | Standard Deviation 15.895377 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 16.771667 percentage of saturation | Standard Deviation 11.701778 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 75.233333 percentage of saturation | Standard Deviation 19.819048 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 41.266667 percentage of saturation | Standard Deviation 14.069921 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 10 hrs | 27.416667 percentage of saturation | Standard Deviation 13.433453 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 34.5 percentage of saturation | Standard Deviation 12.94805 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 21.486667 percentage of saturation | Standard Deviation 10.91862 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 45.016667 percentage of saturation | Standard Deviation 11.995902 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 3 hrs | 78.15 percentage of saturation | Standard Deviation 14.831015 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 5 hrs | 89.516667 percentage of saturation | Standard Deviation 12.587679 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 26.383333 percentage of saturation | Standard Deviation 10.936986 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 35.716667 percentage of saturation | Standard Deviation 11.168781 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 63.05 percentage of saturation | Standard Deviation 13.895719 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 88.8 percentage of saturation | Standard Deviation 11.348128 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4.5 hrs | 88.24 percentage of saturation | Standard Deviation 13.994034 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 74.133333 percentage of saturation | Standard Deviation 19.031938 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 7.5 hrs | 65.2 percentage of saturation | Standard Deviation 18.721218 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 8 hrs | 56.15 percentage of saturation | Standard Deviation 19.282298 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 50.483333 percentage of saturation | Standard Deviation 18.139506 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 10 hrs | 40.133333 percentage of saturation | Standard Deviation 17.189842 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 28.783333 percentage of saturation | Standard Deviation 13.911925 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 25.618333 percentage of saturation | Standard Deviation 12.537496 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 15.85 percentage of saturation | Standard Deviation 4.4440972 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 16.025 percentage of saturation | Standard Deviation 7.9655351 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 22.733333 percentage of saturation | Standard Deviation 8.7016474 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 17.441667 percentage of saturation | Standard Deviation 9.7067696 |
| Cohort 3 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 31.766667 percentage of saturation | Standard Deviation 17.181928 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 22.2 percentage of saturation | Standard Deviation 12.467879 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 65.816667 percentage of saturation | Standard Deviation 13.489613 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 8 hrs | 74.316667 percentage of saturation | Standard Deviation 15.067902 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 7.5 hrs | 80.483333 percentage of saturation | Standard Deviation 13.813532 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 79.45 percentage of saturation | Standard Deviation 14.417039 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 18.633333 percentage of saturation | Standard Deviation 10.414157 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 5 hrs | 98.716667 percentage of saturation | Standard Deviation 9.4961922 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 102.83333 percentage of saturation | Standard Deviation 7.5210815 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 3 hrs | 96.066667 percentage of saturation | Standard Deviation 12.873176 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 58.583333 percentage of saturation | Standard Deviation 11.177373 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 24.483333 percentage of saturation | Standard Deviation 8.0759932 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 47.85 percentage of saturation | Standard Deviation 10.774368 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 39.066667 percentage of saturation | Standard Deviation 10.129495 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 93.966667 percentage of saturation | Standard Deviation 11.727688 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 41.58 percentage of saturation | Standard Deviation 8.2156558 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 18.213333 percentage of saturation | Standard Deviation 5.4371561 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 28.716667 percentage of saturation | Standard Deviation 13.00514 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 36.866667 percentage of saturation | Standard Deviation 14.673196 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 39.866667 percentage of saturation | Standard Deviation 13.873812 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 10 hrs | 55.366667 percentage of saturation | Standard Deviation 15.617127 |
| Cohort 6 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) | t = 4.5 hrs | 102.93333 percentage of saturation | Standard Deviation 10.715721 |
Secondary
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time frame: 48 hours
Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 18 hrs | 18.766667 percentage of saturation | Standard Deviation 1.5821926 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 31.925 percentage of saturation | Standard Deviation 12.673956 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 31.55 percentage of saturation | Standard Deviation 4.2930176 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 30.95 percentage of saturation | Standard Deviation 3.2583227 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 23.7 percentage of saturation | Standard Deviation 7.7948701 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 30 hrs | 30.266667 percentage of saturation | Standard Deviation 11.83737 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 18.833333 percentage of saturation | Standard Deviation 0.5507571 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 21.766667 percentage of saturation | Standard Deviation 6.7337459 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 34.525 percentage of saturation | Standard Deviation 5.4267086 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 20.333333 percentage of saturation | Standard Deviation 3.6855574 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 33.133333 percentage of saturation | Standard Deviation 3.1817186 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 30.766667 percentage of saturation | Standard Deviation 4.5763887 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 38.95 percentage of saturation | Standard Deviation 7.485319 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 20.7 percentage of saturation | Standard Deviation 7.2297994 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 22.133333 percentage of saturation | Standard Deviation 5.0895317 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 40.625 percentage of saturation | Standard Deviation 11.092452 |
| Cohorts 1 - 3, 6 Placebo | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 32.875 percentage of saturation | Standard Deviation 4.7422744 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 38.366667 percentage of saturation | Standard Deviation 13.245628 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 26.5 percentage of saturation | Standard Deviation 10.784062 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 32.6 percentage of saturation | Standard Deviation 11.667219 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 38.633333 percentage of saturation | Standard Deviation 11.449658 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 50 percentage of saturation | Standard Deviation 12.552928 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 67.55 percentage of saturation | Standard Deviation 12.12151 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 73.56 percentage of saturation | Standard Deviation 12.108179 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 78.7 percentage of saturation | Standard Deviation 16.428025 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 78.816667 percentage of saturation | Standard Deviation 17.543935 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 71.483333 percentage of saturation | Standard Deviation 20.245238 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 57.733333 percentage of saturation | Standard Deviation 15.467471 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 18 hrs | 26.5 percentage of saturation | Standard Deviation 10.654201 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 19.238333 percentage of saturation | Standard Deviation 7.7310036 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 17.683333 percentage of saturation | Standard Deviation 4.5845029 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 30 hrs | 15.983333 percentage of saturation | Standard Deviation 3.8012717 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 13.403333 percentage of saturation | Standard Deviation 6.1446128 |
| Cohort 1 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 32.44 percentage of saturation | Standard Deviation 17.400661 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 0.5 hrs | 41.3 percentage of saturation | Standard Deviation 11.031591 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 18 hrs | 43.433333 percentage of saturation | Standard Deviation 14.76383 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 4 hrs | 92.833333 percentage of saturation | Standard Deviation 14.211498 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 48 hrs | 34.633333 percentage of saturation | Standard Deviation 12.038383 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 20 hrs | 29.966667 percentage of saturation | Standard Deviation 11.375178 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 2 hrs | 67.266667 percentage of saturation | Standard Deviation 13.599069 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 36 hrs | 17.383333 percentage of saturation | Standard Deviation 8.9302669 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 24 hrs | 22.783333 percentage of saturation | Standard Deviation 7.0024043 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 1 hr | 50.283333 percentage of saturation | Standard Deviation 10.526997 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 0 hrs | 32.45 percentage of saturation | Standard Deviation 10.532379 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 12.5 hrs | 100.31667 percentage of saturation | Standard Deviation 12.198429 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 30 hrs | 18.45 percentage of saturation | Standard Deviation 5.9949145 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 14 hrs | 82.15 percentage of saturation | Standard Deviation 15.394902 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 12 hrs | 104.9 percentage of saturation | Standard Deviation 10.529008 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 9 hrs | 107.55 percentage of saturation | Standard Deviation 6.8625797 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 16 hrs | 61.3 percentage of saturation | Standard Deviation 17.549473 |
| Cohort 2 SFP | Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) | t = 6 hrs | 108.86667 percentage of saturation | Standard Deviation 16.846325 |