Anemia, Iron Deficiency
Conditions
Keywords
iron deficiency, anaemia
Brief summary
The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.
Detailed description
Open-label, Phase 1, four way crossover study to compare the PK of the new ferric maltol suspension, in healthy volunteers, with the existing ferric maltol capsules under fed and fasted conditions. 32 subjects will be randomised to 1:1:1:1 ratio to receive one of the treatment sequences. Based on the randomised sequence, subjects will receive a single dose of 30mg ferric maltol capsule in a fed/ fasted condition and 30 mg (5ml) ferric maltol suspension in a fed/ fasted condition. Subject participation in the study will consist of 3 periods: 1. Screening: up to 14 days 2. Randomised treatment: 8 days 3. Post-treatment follow up: 3-7 days following drug discontinuation
Interventions
DRUGFerric maltol capsule
single dose of 30 mg capsule
DRUGFerric maltol suspension
single dose of 30mg (5ml) oral suspension
Sponsors
Shield Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomized 1:1:1:1 to one of the treatment sequences. ie. single dose of 30 mg ferric maltol capsule in a fed condition single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition single dose of 30 mg ferric maltol capsule in a fasted condition single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
All of the following criteria must be met for a subject to participate in the study: 1. Must voluntarily sign and date each Institutional Review Board (IRB)-approved informed consent form (ICF) prior to the initiation of any screening or study-specific procedures. 2. Willing and able to comply with study requirements. 3. Healthy adult subjects 18 to 55 years of age, inclusive at the time of informed consent. 4. Body Mass Index (BMI) of 18-32 kg/m2 inclusive 5. Female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. All female subjects must have a negative result for the pregnancy tests performed at screening and each treatment period. 6. Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implants, injection, ring, or patch) and intrauterine contraceptive devices (IUDs), at least 3 months prior to Screening, or a vasectomized partner. Note: complete abstinence from sexual intercourse is an acceptable form of contraceptive practice. 7. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral, tubal ligation, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for at least 2 years 8. Male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to Screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse from Study Day -1 (beginning of confinement) until 3 months after the Follow-up Visit. Note: Complete abstinence from sexual intercourse is an acceptable form of contraceptive practice. 9. Male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after administration of the last dose of study drug.
Exclusion criteria
A subject who meets any of the following criteria is not eligible for participation in the study. 1. Known hypersensitivity or allergy to the active substance or excipients of Ferric maltol oral suspension or capsules; 2. Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, as determined by the Investigator; 3. Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines; 4. Recent (within 6 months of screening) history of drug or alcohol abuse; 5. Positive screen results for drugs of abuse, alcohol at screening or Study Day -1 of Period1; 6. Consumption of alcohol within 72 hrs prior to study drug administration; 7. Positive test result for hepatitis B surface antigen (HBSaAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening; 8. Donation or loss of 550 mL or more blood volume or receipt of a transfusions of any blood product within 8 weeks prior to study drug administration and 14 days for plasma donation unless medically inadvisable; 9. Use of any over the counter medications, including herbal product within 7 days prior to Screening until study completion. Except for ordinary pain (e.g. headache), some analgesics (mainly paracetamol) and contraception which have no drug interactions with the study products may be given; 10. Has received within 28 days prior to Screening intramuscular or intravenous (IV) injection or administration of depot iron preparation; 11. Has received oral iron supplementation within 7 days prior to Screening; 12. Has concomitant disease that would significantly compromise iron absorption or absorbed iron utilization such as swallowing disorders, gastric pH-disturbance and/or extensive small bowel resection; 13. Scheduled or expected hospitalization and/or surgery during the course of the study; 14. Diagnosed to be COVID-19 positive by polymerase chain reaction testing (SARS-CoV-2-RTPCR positive) of a respiratory specimen (preferably a nasopharyngeal swab) on Day -2; 15. Participation in any other interventional clinical study within 28 days prior to Screening; 16. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor makes the subject unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition | Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension. |
| Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition | Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension |
| Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition | Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension |
| Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition | Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension |
| Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Capsule | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days | Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg ferric maltol capsule |
| Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Capsule | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days | Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30 mg ferric maltol capsule |
| Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Suspension | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days | Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension |
| Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Suspension | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days | Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Analysis of TSAT; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of TSAT; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of transferrin saturation; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of TIBC; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of TIBC; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Total Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| Summary of Serious Adverse Events | up to 2 weeks following last dose | Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted) |
| PK Analysis of UIBC; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of UIBC; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1,1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Unsaturated Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted) |
| PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of transferrin; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| Treatment-Emergent Adverse Events | From first dose of ferric maltol on Day 1 to study completion | Treatment-Emergent Adverse Events from Day 1 to Day 22 (Study completion) |
| TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments | From first dose of ferric maltol on Day 1 to study completion | TEAE leading to premature discontinuation of study drug/PK assessments from Day 1 to study completion |
| Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Screening to Day 8 | Descriptive statistics for changes in blood pressure from Screening to Day 8 |
| Vital Signs - Heart Rate, Change From Day 1 to Day 7 | Screening to Day 7 | Descriptive statistics for changes in heart rate from Screening to Day 7 |
| Summary of Received Concomitant Medication by Formulation | Day 1 to Day 8 (24 hrs post-dose of last dosing) | Number of participants having received concomitant medications by formulation (suspension or capsule) |
| PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of baseline corrected serum iron concentration; area under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Baseline Corrected Serum Iron Concentration; AUCinf in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of baseline corrected serum iron concentration; Area Under the Curve from 0-infinity by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of maltol glucuronide; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Maltol; Cmax in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted) |
| PK Analysis of Maltol; AUClast in Fasted and Fed Conditions | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose | Descriptive statistics of maltol; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted) |
Countries
United States
Participant flow
Recruitment details
32 subjects recruited. 8 subjects randomised to each sequence.
Participants by arm
| Arm | Count |
|---|---|
| Ferric Maltol Sequence A Period 1 capsule-fed; Period 2 suspension fed; Period 3 capsule fasted; Period 4 suspension fasted. | 8 |
| Ferric Maltol Sequence B Period 1 suspension fasted; Period 2 capsule-fed; Period 3 suspension fed; Period 4 capsule fasted. | 8 |
| Ferric Maltol Sequence C Period 1 capsule fasted; Period 2 suspension fasted; Period 3 capsule fed; Period 4 suspension fed. | 8 |
| Ferric Maltol Sequence D Period 1 suspension fed; Period 2 capsule fasted; Period 3 suspension fasted; Period 4 capsule fed. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Ferric Maltol Sequence A | Ferric Maltol Sequence B | Ferric Maltol Sequence C | Ferric Maltol Sequence D | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 32 Participants |
| Age, Continuous | 36.6 years STANDARD_DEVIATION 9.33 | 34.00 years STANDARD_DEVIATION 11.05 | 33.6 years STANDARD_DEVIATION 6.44 | 40.5 years STANDARD_DEVIATION 8.82 | 36.18 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 7 Participants | 6 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 6 Participants | 5 Participants | 5 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants | 8 participants | 32 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 4 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 2 / 32 | 3 / 32 | 3 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 32 | 0 / 32 |
Outcome results
Primary
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Population: FAS
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition | 77.54 ratio |
Primary
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
Population: Full analysis set population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition | 96.99 ratio |
Primary
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Capsule
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30 mg ferric maltol capsule
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days
Population: FAS
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Capsule | 134.25 ratio |
Primary
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Suspension
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days
Population: FAS
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Suspension | 107.32 ratio |
Primary
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
Population: Full analysis set population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition | 99.11 ratio |
Primary
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Population: Full Analysis Set Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition | 69.94 ratio |
Primary
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Capsule
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg ferric maltol capsule
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days
Population: Full Analysis Set Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Capsule | 147.27 ratio |
Primary
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Suspension
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days
Population: FAS
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Suspension | 103.93 ratio |
Secondary
PK Analysis of Baseline Corrected Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
Descriptive statistics of baseline corrected serum iron concentration; Area Under the Curve from 0-infinity by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS. If the Lambda z was not assigned, the values of associated PK parameters AUCinf was not calculated.
Secondary
PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions
Descriptive statistics of baseline corrected serum iron concentration; area under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions | 56.150 h*ng/mL | Standard Deviation 964.9572 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions | 691.392 h*ng/mL | Standard Deviation 791.8671 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions | 2.503 h*ng/mL | Standard Deviation 889.0745 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions | -9.436 h*ng/mL | Standard Deviation 693.283 |
Secondary
PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions
Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions | 44.469 ng/mL | Standard Deviation 73.0572 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions | 89.938 ng/mL | Standard Deviation 50.9927 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions | 40.219 ng/mL | Standard Deviation 52.9715 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions | 33.250 ng/mL | Standard Deviation 23.0637 |
Secondary
PK Analysis of Maltol; AUClast in Fasted and Fed Conditions
Descriptive statistics of maltol; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS - If the Lambda z was not assigned, the values of associated PK parameters AUC last was not calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol; AUClast in Fasted and Fed Conditions | 28.61 h*ng/mL | Standard Deviation 21.924 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Maltol; AUClast in Fasted and Fed Conditions | 17.29 h*ng/mL | Standard Deviation 15.274 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Maltol; AUClast in Fasted and Fed Conditions | 39.13 h*ng/mL | Standard Deviation 44.525 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol; AUClast in Fasted and Fed Conditions | 22.41 h*ng/mL | Standard Deviation 16.879 |
Secondary
PK Analysis of Maltol; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol; Cmax in Fasted and Fed Conditions | 16.994 ng/mL | Standard Deviation 18.542 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Maltol; Cmax in Fasted and Fed Conditions | 20.531 ng/mL | Standard Deviation 16.0714 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Maltol; Cmax in Fasted and Fed Conditions | 33.600 ng/mL | Standard Deviation 37.0501 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol; Cmax in Fasted and Fed Conditions | 34.656 ng/mL | Standard Deviation 25.2179 |
Secondary
PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions
Descriptive statistics of maltol glucuronide; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions | 7335.93 h*ng/mL | Standard Deviation 2449.53 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions | 9083.82 h*ng/mL | Standard Deviation 2902.863 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions | 7802.52 h*ng/mL | Standard Deviation 2585.848 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions | 10410.89 h*ng/mL | Standard Deviation 2631.072 |
Secondary
PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions | 3579.063 ng/mL | Standard Deviation 1668.212 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions | 5126.250 ng/mL | Standard Deviation 1996.0748 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions | 3597.500 ng/mL | Standard Deviation 1776.439 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions | 7685.0 ng/mL | Standard Deviation 1920.3797 |
Secondary
PK Analysis of TIBC; AUClast in Fasted and Fed Conditions
Descriptive statistics of Total Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TIBC; AUClast in Fasted and Fed Conditions | 8719.09 h*ng/mL | Standard Deviation 1097.981 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of TIBC; AUClast in Fasted and Fed Conditions | 8880.52 h*ng/mL | Standard Deviation 1165.547 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of TIBC; AUClast in Fasted and Fed Conditions | 8718.02 h*ng/mL | Standard Deviation 1195.335 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TIBC; AUClast in Fasted and Fed Conditions | 8878.43 h*ng/mL | Standard Deviation 1069.977 |
Secondary
PK Analysis of TIBC; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TIBC; Cmax in Fasted and Fed Conditions | 393.688 ng/mL | Standard Deviation 50.5208 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of TIBC; Cmax in Fasted and Fed Conditions | 394.781 ng/mL | Standard Deviation 50.9913 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of TIBC; Cmax in Fasted and Fed Conditions | 396.938 ng/mL | Standard Deviation 73.3577 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TIBC; Cmax in Fasted and Fed Conditions | 394.656 ng/mL | Standard Deviation 46.531 |
Secondary
PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS - If the Lambda z was not assigned, the values of associated PK parameters AUCinf was not calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions | 2922.46 h*ng/mL | Standard Deviation 1052.46 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions | 3694.05 h*ng/mL | Standard Deviation 1561.138 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions | 3330.98 h*ng/mL | Standard Deviation 2128.861 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions | 3445.41 h*ng/mL | Standard Deviation 2615.954 |
Secondary
PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions
Descriptive statistics of transferrin; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions | 6711.95 h*ng/mL | Standard Deviation 965.632 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions | 6774.38 h*ng/mL | Standard Deviation 948.865 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions | 6701.92 h*ng/mL | Standard Deviation 980.522 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions | 6837.00 h*ng/mL | Standard Deviation 936.103 |
Secondary
PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions
Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions | 304.063 ng/mL | Standard Deviation 42.7332 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions | 302.594 ng/mL | Standard Deviation 44.5051 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions | 300.688 ng/mL | Standard Deviation 42.3316 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions | 303.031 ng/mL | Standard Deviation 40.167 |
Secondary
PK Analysis of TSAT; AUClast in Fasted and Fed Conditions
Descriptive statistics of transferrin saturation; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TSAT; AUClast in Fasted and Fed Conditions | 509.90 h*ng/mL | Standard Deviation 201.915 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of TSAT; AUClast in Fasted and Fed Conditions | 644.62 h*ng/mL | Standard Deviation 176.724 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of TSAT; AUClast in Fasted and Fed Conditions | 484.64 h*ng/mL | Standard Deviation 153.99 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TSAT; AUClast in Fasted and Fed Conditions | 513.62 h*ng/mL | Standard Deviation 193.642 |
Secondary
PK Analysis of TSAT; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TSAT; Cmax in Fasted and Fed Conditions | 32.750 ng/mL | Standard Deviation 18.4793 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of TSAT; Cmax in Fasted and Fed Conditions | 43.031 ng/mL | Standard Deviation 12.9428 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of TSAT; Cmax in Fasted and Fed Conditions | 30.344 ng/mL | Standard Deviation 12.597 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of TSAT; Cmax in Fasted and Fed Conditions | 30.188 ng/mL | Standard Deviation 9.3892 |
Secondary
PK Analysis of UIBC; AUClast in Fasted and Fed Conditions
Descriptive statistics of Unsaturated Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1,1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of UIBC; AUClast in Fasted and Fed Conditions | 6836.84 h*ng/mL | Standard Deviation 1303.757 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of UIBC; AUClast in Fasted and Fed Conditions | 6432.85 h*ng/mL | Standard Deviation 1052.589 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of UIBC; AUClast in Fasted and Fed Conditions | 6939.53 h*ng/mL | Standard Deviation 1159.295 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of UIBC; AUClast in Fasted and Fed Conditions | 6978.71 h*ng/mL | Standard Deviation 1182.131 |
Secondary
PK Analysis of UIBC; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | PK Analysis of UIBC; Cmax in Fasted and Fed Conditions | 329.750 ng/mL | Standard Deviation 57.3298 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | PK Analysis of UIBC; Cmax in Fasted and Fed Conditions | 323.250 ng/mL | Standard Deviation 59.0172 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | PK Analysis of UIBC; Cmax in Fasted and Fed Conditions | 331.250 ng/mL | Standard Deviation 82.0668 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | PK Analysis of UIBC; Cmax in Fasted and Fed Conditions | 322.375 ng/mL | Standard Deviation 55.7018 |
Secondary
Summary of Received Concomitant Medication by Formulation
Number of participants having received concomitant medications by formulation (suspension or capsule)
Time frame: Day 1 to Day 8 (24 hrs post-dose of last dosing)
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Summary of Received Concomitant Medication by Formulation | 2 participants |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | Summary of Received Concomitant Medication by Formulation | 2 participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | Summary of Received Concomitant Medication by Formulation | 2 participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | Summary of Received Concomitant Medication by Formulation | 2 participants |
Secondary
Summary of Serious Adverse Events
Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted)
Time frame: up to 2 weeks following last dose
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Summary of Serious Adverse Events | 0 Participants |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | Summary of Serious Adverse Events | 0 Participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | Summary of Serious Adverse Events | 0 Participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | Summary of Serious Adverse Events | 0 Participants |
Secondary
TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments
TEAE leading to premature discontinuation of study drug/PK assessments from Day 1 to study completion
Time frame: From first dose of ferric maltol on Day 1 to study completion
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments | 0 Participants |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments | 0 Participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments | 0 Participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments | 0 Participants |
Secondary
Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events from Day 1 to Day 22 (Study completion)
Time frame: From first dose of ferric maltol on Day 1 to study completion
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Treatment-Emergent Adverse Events | 0 Participants |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | Treatment-Emergent Adverse Events | 2 Participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | Treatment-Emergent Adverse Events | 3 Participants |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | Treatment-Emergent Adverse Events | 3 Participants |
Secondary
Vital Signs - Blood Pressure, Change From Day 1 to Day 8
Descriptive statistics for changes in blood pressure from Screening to Day 8
Time frame: Screening to Day 8
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Diastolic blood pressure | -0.5 mmHg | Standard Deviation 3.02 |
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Systolic blood pressure | -3.6 mmHg | Standard Deviation 6.25 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Systolic blood pressure | -4.6 mmHg | Standard Deviation 10.9 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Diastolic blood pressure | -0.3 mmHg | Standard Deviation 6.71 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Diastolic blood pressure | -3.6 mmHg | Standard Deviation 7.58 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Systolic blood pressure | -4.9 mmHg | Standard Deviation 14.59 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Diastolic blood pressure | -2.4 mmHg | Standard Deviation 4.63 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Systolic blood pressure | -0.1 mmHg | Standard Deviation 7.16 |
Secondary
Vital Signs - Heart Rate, Change From Day 1 to Day 7
Descriptive statistics for changes in heart rate from Screening to Day 7
Time frame: Screening to Day 7
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition | Vital Signs - Heart Rate, Change From Day 1 to Day 7 | -0.8 beats/min | Standard Deviation 10.26 |
| 30 mg Ferric Maltol Capsule in a Fasted Condition | Vital Signs - Heart Rate, Change From Day 1 to Day 7 | 8.1 beats/min | Standard Deviation 8.69 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition | Vital Signs - Heart Rate, Change From Day 1 to Day 7 | 11.1 beats/min | Standard Deviation 11.23 |
| 30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition | Vital Signs - Heart Rate, Change From Day 1 to Day 7 | 3.1 beats/min | Standard Deviation 6.13 |