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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-2544 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Etavopivat: fed-fasted | Experimental | Participants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2. |
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| Sequence 2: Etavopivat: fasted-fed | Experimental | Participants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etavopivat | Drug | Participants will receive single dose of oral Etavopivat in each treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose | Measured as hours nanograms per milliliter (h*ng/mL). | From 0 to 120 hours after IMP administration (V2/V6) |
| Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose | Measured as nanograms per milliliter (ng/mL). | From 0 to 120 hours after IMP administration (V2/V6) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration | Measured as hours nanograms per milliliter (h*ng/ml). | From 0 to 120 hours after IMP administration (V2/V6) |
| tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON-Salt Lake City | Salt Lake City | Utah | 84124 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Measured as hours. |
| From 0 to 120 hours after IMP administration (V2/V6) |
| t1/2, etavopivat: Terminal half-life for etavopivat after a single dose | Measured as hours. | From 0 to 120 hours after IMP administration (V2/V6) |
| CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose | Measured as liter per hours (L/h). | From 0 to 120 hours after IMP administration (V2/V6) |
| Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values | Measured as liters (L). | From 0 to 120 hours after IMP administration (V2/V6) |
| Number of adverse events | Measured as count of events. | From IMP administration on day 1 to completion of the end of study visit (V10) |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |