Prolonged QTc Interval
Conditions
Keywords
Ferriprox®, LI, DFP, Deferiprone, Healthy Volunteers
Brief summary
Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover study to evaluate the effect of deferiprone on QTc prolongation after administration of a single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in healthy volunteers as compared to placebo treatment.
Detailed description
Post-marketing study to evaluate the effect of deferiprone and deferiprone 3-O-glucuronide on QTc prolongation in healthy volunteers after administration of a single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral dose of deferiprone and moxifloxacin (Avelox®).
Interventions
DRUGDeferiprone
Ferriprox 500 mg tablets
DRUGdeferiprone matching placebo tablets
deferiprone matching placebo tablets
DRUGmoxifloxacin
Active control
DRUGplacebo
moxifloxacin-matching placebo
Sponsors
ApoPharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: 1. Healthy adult males or females, 18 - 45 years of age (inclusive). 2. Body weight ≥ 50 kg. 3. Body mass index (BMI) ≥ 19 and ≤ 32 kg/m2. 4. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination). 5. Absolute neutrophil count (ANC) of \>1.5x109/L. 6. 12-lead ECGs which have no clinically significant findings as judged by the Principal Investigator (PI) or the PI's designee at screening and check-in of each study period,including: 1. Normal sinus rhythm (heart rate between 45 and 100 bpm); 2. QTcF interval ≤ 450 msec; 3. QRS interval ≤ 110 msec; and 4. PR interval ≤ 220 msec. 7. Subject must be capable of providing written informed consent, and must voluntarily consent to participate in the study. 8. Willing to answer inclusion and
Exclusion criteria
questionnaire at check-in. Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone | 24-hour interval | Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone | 24-hour interval | Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| Maximum Postdose QT/QTc Interval | 24-hour interval | The maximum post-dose QT/QTc interval for deferiprone and placebo. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| Maximum Change From Baseline (dQT/dQTc) | 24-hour interval | Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24-hour interval | T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| Tmax of Deferiprone and Deferiprone 3-O-glucuronide | 24-hour interval | To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin | 24-hour interval | Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| Number of Participants With Adverse Events | From administration of the first dose until 7 days +/- 1 day following the final dose | Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone |
| Cmax of Deferiprone and Deferiprone 3-O Glucuronide | 24-hour interval | To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
| AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24-hour interval | AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose. |
Countries
United States
Participant flow
Recruitment details
First subject enrolled: 17 November 2012 Last subject completed: 19 December 2012 The study was carried out at Celerion, a research facility used for conducting clinical trials.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 | 0 | 2 |
| Overall Study | Personal reason | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 21 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 46 | 35 / 48 | 10 / 45 | 5 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 | 0 / 45 | 0 / 46 |
Outcome results
Primary
Maximum Change From Baseline (dQT/dQTc)
Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 33 mg/kg Deferiprone | Maximum Change From Baseline (dQT/dQTc) | QTcF ≤ 30 msec | 100 percentage of participants |
| 33 mg/kg Deferiprone | Maximum Change From Baseline (dQT/dQTc) | QTcF >60 msec | 0 percentage of participants |
| 33 mg/kg Deferiprone | Maximum Change From Baseline (dQT/dQTc) | QTcF >30 but ≤ 60 msec | 0 percentage of participants |
| Placebo Control | Maximum Change From Baseline (dQT/dQTc) | QTcF ≤ 30 msec | 100 percentage of participants |
| Placebo Control | Maximum Change From Baseline (dQT/dQTc) | QTcF >60 msec | 0 percentage of participants |
| Placebo Control | Maximum Change From Baseline (dQT/dQTc) | QTcF >30 but ≤ 60 msec | 0 percentage of participants |
| Arm C - Placebo Control | Maximum Change From Baseline (dQT/dQTc) | QTcF >30 but ≤ 60 msec | 0 percentage of participants |
| Arm C - Placebo Control | Maximum Change From Baseline (dQT/dQTc) | QTcF ≤ 30 msec | 100 percentage of participants |
| Arm C - Placebo Control | Maximum Change From Baseline (dQT/dQTc) | QTcF >60 msec | 0 percentage of participants |
| Arm D - Positive Control | Maximum Change From Baseline (dQT/dQTc) | QTcF ≤ 30 msec | 96 percentage of participants |
| Arm D - Positive Control | Maximum Change From Baseline (dQT/dQTc) | QTcF >60 msec | 0 percentage of participants |
| Arm D - Positive Control | Maximum Change From Baseline (dQT/dQTc) | QTcF >30 but ≤ 60 msec | 4 percentage of participants |
Primary
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 33 mg/kg Deferiprone | Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone | 1.4 milliseconds | Standard Deviation 4.92 |
| Placebo Control | Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone | -1.6 milliseconds | Standard Deviation 4.72 |
90% CI: [1.02, 5.01]
Primary
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 33 mg/kg Deferiprone | Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone | 3.5 milliseconds | Standard Deviation 5.28 |
| Placebo Control | Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone | -1.7 milliseconds | Standard Deviation 6.36 |
90% CI: [3.26, 7.19]
Primary
Maximum Postdose QT/QTc Interval
The maximum post-dose QT/QTc interval for deferiprone and placebo. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 33 mg/kg Deferiprone | Maximum Postdose QT/QTc Interval | QTcF ≤ 450 msec | 100 percentage of participants |
| 33 mg/kg Deferiprone | Maximum Postdose QT/QTc Interval | QTcF > 450 to ≤ 480 msec | 0 percentage of participants |
| 33 mg/kg Deferiprone | Maximum Postdose QT/QTc Interval | QTcF > 480 to ≤ 500 msec | 0 percentage of participants |
| 33 mg/kg Deferiprone | Maximum Postdose QT/QTc Interval | QTcF > 500 msec | 0 percentage of participants |
| Placebo Control | Maximum Postdose QT/QTc Interval | QTcF > 450 to ≤ 480 msec | 4 percentage of participants |
| Placebo Control | Maximum Postdose QT/QTc Interval | QTcF > 480 to ≤ 500 msec | 0 percentage of participants |
| Placebo Control | Maximum Postdose QT/QTc Interval | QTcF > 500 msec | 0 percentage of participants |
| Placebo Control | Maximum Postdose QT/QTc Interval | QTcF ≤ 450 msec | 96 percentage of participants |
| Arm C - Placebo Control | Maximum Postdose QT/QTc Interval | QTcF > 480 to ≤ 500 msec | 0 percentage of participants |
| Arm C - Placebo Control | Maximum Postdose QT/QTc Interval | QTcF > 450 to ≤ 480 msec | 2 percentage of participants |
| Arm C - Placebo Control | Maximum Postdose QT/QTc Interval | QTcF > 500 msec | 0 percentage of participants |
| Arm C - Placebo Control | Maximum Postdose QT/QTc Interval | QTcF ≤ 450 msec | 98 percentage of participants |
| Arm D - Positive Control | Maximum Postdose QT/QTc Interval | QTcF > 500 msec | 0 percentage of participants |
| Arm D - Positive Control | Maximum Postdose QT/QTc Interval | QTcF > 450 to ≤ 480 msec | 11 percentage of participants |
| Arm D - Positive Control | Maximum Postdose QT/QTc Interval | QTcF ≤ 450 msec | 89 percentage of participants |
| Arm D - Positive Control | Maximum Postdose QT/QTc Interval | QTcF > 480 to ≤ 500 msec | 0 percentage of participants |
Secondary
AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 33 mg/kg Deferiprone | AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-infinity for serum deferiprone | 95.4 μg *hr/mL | Standard Deviation 18.03 |
| 33 mg/kg Deferiprone | AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-infinity for serum deferiprone -O-glucuronide | 205.5 μg *hr/mL | Standard Deviation 42.8 |
| Placebo Control | AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-infinity for serum deferiprone | 152.1 μg *hr/mL | Standard Deviation 22.2 |
| Placebo Control | AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-infinity for serum deferiprone -O-glucuronide | 331.2 μg *hr/mL | Standard Deviation 74.7 |
Secondary
Cmax of Deferiprone and Deferiprone 3-O Glucuronide
To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 33 mg/kg Deferiprone | Cmax of Deferiprone and Deferiprone 3-O Glucuronide | Cmax of serum deferiprone | 34.1 μg/mL | Standard Deviation 8.9 |
| 33 mg/kg Deferiprone | Cmax of Deferiprone and Deferiprone 3-O Glucuronide | Cmax of serum deferiprone 3-O-glucuronide | 35.2 μg/mL | Standard Deviation 8.5 |
| Placebo Control | Cmax of Deferiprone and Deferiprone 3-O Glucuronide | Cmax of serum deferiprone | 54.4 μg/mL | Standard Deviation 16.4 |
| Placebo Control | Cmax of Deferiprone and Deferiprone 3-O Glucuronide | Cmax of serum deferiprone 3-O-glucuronide | 51.4 μg/mL | Standard Deviation 13.4 |
Secondary
Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin
Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval. ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 33 mg/kg Deferiprone | Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin | 14.7 milliseconds | Standard Deviation 6.38 |
| Placebo Control | Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin | 1.2 milliseconds | Standard Deviation 6.46 |
90% CI: [11.1, 15.75]
Secondary
Number of Participants With Adverse Events
Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone
Time frame: From administration of the first dose until 7 days +/- 1 day following the final dose
Population: The Safety Analysis Set consisted of all subjects who received at least 1 dose of study medication and had at least 1 safety assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 33 mg/kg Deferiprone | Number of Participants With Adverse Events | 12 participants |
| Placebo Control | Number of Participants With Adverse Events | 35 participants |
| Arm C - Placebo Control | Number of Participants With Adverse Events | 10 participants |
| Arm D - Positive Control | Number of Participants With Adverse Events | 5 participants |
Secondary
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 33 mg/kg Deferiprone | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for serum deferiprone | 1.8 hour | Standard Deviation 0.3 |
| 33 mg/kg Deferiprone | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for serum deferiprone 3-O-glucuronide | 2.5 hour | Standard Deviation 0.5 |
| Placebo Control | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for serum deferiprone | 1.8 hour | Standard Deviation 0.3 |
| Placebo Control | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for serum deferiprone 3-O-glucuronide | 2.6 hour | Standard Deviation 0.2 |
Secondary
Tmax of Deferiprone and Deferiprone 3-O-glucuronide
To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers. Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.
Time frame: 24-hour interval
Population: The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| 33 mg/kg Deferiprone | Tmax of Deferiprone and Deferiprone 3-O-glucuronide | Tmax of serum deferiprone | 0.8185 hour | Full Range 0.6 |
| 33 mg/kg Deferiprone | Tmax of Deferiprone and Deferiprone 3-O-glucuronide | Tmax of serum deferiprone -O-glucuronide | 3.066 hour | Full Range 0.7 |
| Placebo Control | Tmax of Deferiprone and Deferiprone 3-O-glucuronide | Tmax of serum deferiprone | 0.8175 hour | Full Range 0.9 |
| Placebo Control | Tmax of Deferiprone and Deferiprone 3-O-glucuronide | Tmax of serum deferiprone -O-glucuronide | 3.071 hour | Full Range 0.7 |