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The primary purpose of this study is to assess the relative bioavailability of the mitapivat coated granule formulation compared to the tablet formulation following a single oral dose of mitapivat under fasted conditions in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: ABCD | Experimental | Participants will receive Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 1) followed by Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 2) followed by Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 3) followed by Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days. |
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| Treatment Sequence 2: BDAC | Experimental | Participants will receive Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 1) followed by Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 2) followed by Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 3) followed by Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days. |
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| Treatment Sequence 3: CADB | Experimental | Participants will receive Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 1) followed by Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 2) followed by Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 3) followed by Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitapivat tablets | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Mitapivat Under Fasted Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) | |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-t) of Mitapivat Under Fasted Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) | |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of Mitapivat Under Fasted Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) | |
| Time to Reach Maximum Observed Concentration (Tmax) of Mitapivat Under Fasted Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Mitapivat Under Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) | |
| AUC0-t of Mitapivat Under Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Dallas | Texas | 75247 | United States |
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| Treatment Sequence 4: DCBA | Experimental | Participants will receive Treatment D (mitapivat coated granules, with a chocolate pudding, orally once on Day 1 of Period 1) followed by Treatment C (mitapivat coated granules, with a strawberry yogurt, orally once on Day 1 of Period 2) followed by Treatment B (mitapivat coated granules, orally, under fasted conditions once on Day 1 of Period 3) followed by Treatment A (mitapivat tablet, orally, under fasted conditions once on Day 1 of Period 4). Each Treatment Period will be separated by a Washout Period of 7 days. |
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| Mitapivat coated granules | Drug | Oral coated granules |
|
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| AUC0-∞ of Mitapivat Under Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Tmax of Mitapivat Under Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Relative Bioavailability (Frel) Under Fasted and Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Twelve Hours (AUC0-12) of Mitapivat Under Fasted and Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Apparent Plasma Terminal Elimination Half-life (t½) of Mitapivat Under Fasted and Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Apparent Total Plasma Clearance (CL/F) of Mitapivat Under Fasted and Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Apparent Volume of Distribution (Vz/F) of Mitapivat Under Fasted and Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Apparent Terminal Elimination Rate Constant (λz) of Mitapivat Under Fasted and Fed Conditions | Pre-dose and multiple time points post-dose (up to 72 hours) |
| Number of Participants With Adverse Event (AEs) | Up to approximately 9 weeks |
| Number of Participants With AEs, Graded by Severity | Up to approximately 9 weeks |
| Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values | Up to approximately 9 weeks |
| Number of Participants With Clinically Significant Abnormal Findings for 12-lead Electrocardiogram (ECG) Parameters | Up to approximately 9 weeks |
| Number of Participants With Clinically Significant Abnormal Findings for Vital Signs Parameters | Up to approximately 9 weeks |
| Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Up to approximately 9 weeks |
| ID | Term |
|---|---|
| C000634504 | mitapivat |
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