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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-5780 | Other Identifier | Universal Trial Number |
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Novo Nordisk is developing a new study medicine, Etavopivat, to treat individuals with sickle cell disease (SCD). The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts: Part A and Part B. Part A investigates the safety of a high dose of Etavopivat. In this phase, participants will receive either a single dose of Etavopivat or a placebo. Which treatment the participant gets is decided by chance. In Part B, participants will get four different treatments on four different occasions: Etavopivat in 2 different doses (the new medicine that cannot be prescribed), a dummy medicine (placebo), and an already approved medicine (moxifloxacin). The order of the 4 study medicines is decided by chance. There will be a break of 7 days between each treatment. For Part A, the study duration will be from 10 to 36 days, and for Part B, the study duration will be from 27 to 53 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A- Etavopivat | Experimental | Participants will receive a single dose of etavopivat. |
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| Part A- Placebo | Placebo Comparator | Participants will receive a single dose of placebo. |
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| Part B- Etavopivat | Experimental | Participants will receive a single dose of etavopivat. |
|
| Part B- Moxifloxacin | Other | Participants will receive a single dose of moxifloxacin. |
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| Part B- Placebo | Placebo Comparator | Participants will receive a single dose of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etavopivat | Drug | Etavopivat will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment-emergent adverse events (AEs) | Measured as count of events. | From dosing (Day 1) until end of study (Day 8) |
| Part B: Change from baseline in Fridericia heart rate corrected QT interval (ΔQTcF) for etavopivat | Measured as milliseconds. | From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment-emergent clinically significant abnormal findings in electrocardiogram (ECGs) | Measured as count of treatment-emergent clinically significant abnormal findings in ECGs. | From dosing (Day 1) until end of study (Day 8) |
| Parts A and B: Cmax,etavopivat- Maximum observed etavopivat plasma concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
A minimum of 20% African-American participants will be included in each part of this study.
Efforts will be made to include at least 40 percentage (%) of each sex into each part of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Intl - EPCU-Baltimore | Baltimore | Maryland | 21225 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Moxifloxacin will be administered orally. |
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| Placebo | Drug | Placebo matching Etavopivat will be administered orally. |
|
Measured as nanograms per milliliter (ng/mL). |
| Day 1 (Part B)/ From day 1 to day 5 (Part A) after investigational medicinal product (IMP) administration |
| Parts A and B: 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). | Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration |
| Parts A and B: AUC0-inf,etavopivat- Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose | Measured as h*ng/mL. | Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration |
| Parts A and B: tmax,etavopivat- Time to maximum observed etavopivat plasma concentration after a single dose | Measured as hours. | Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration |
| Parts A and B: t½ etavopivat- Terminal half-life for etavopivat after a single dose | Measured as hours. | Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration |
| Parts A and B: CL/F etavopivat- Apparent plasma clearance of etavopivat after a single dose | Measured as liters per hour (L/h). | Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration |
| Parts A and B: Vz/F etavopivat- Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values | Measured as liters (L). | Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration |
| Part B: ΔQTcF for moxifloxacin | Measured as milliseconds. | From pre-dose to post moxifloxacin dose on day 1 to day 23 |
| Part B: Change from baseline in heart rate (ΔHR). Categorical outliers for HR | Measured as milliseconds. | From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23 |
| Part B: Change from baseline in PR interval (ΔPR). Categorical outliers for PR | Measured as milliseconds. | From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23 |
| Part B: Change from baseline in QRS complex duration (ΔQRS). Categorical outliers for QRS | Measured as milliseconds. | From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23 |
| Part B: Frequency of treatment emergent changes of ECG morphology | Measured as count of treatment emergent changes of ECG morphology. | From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23 |
| Part B: Change from baseline in ΔHR. Categorical outliers for HR | Measured as milliseconds. | From pre-dose to post moxifloxacin dose on day 1 to day 23 |
| Part B: Change from baseline in ΔPR. Categorical outliers for PR | Measured as milliseconds. | From pre-dose to post moxifloxacin dose on day 1 to day 23 |
| Part B: Change from baseline in ΔQRS. Categorical outliers for QRS | Measured as milliseconds. | From pre-dose to post moxifloxacin dose on day 1 to day 23 |
| Part B: Frequency of treatment emergent changes of ECG morphology | Measured as count of treatment emergent changes of ECG morphology. | From pre-dose to post moxifloxacin dose on day 1 to day 23 |
| Part B: ΔQTcF for etavopivat | Measured as milliseconds. | From pre-dose to post etavopivat/etavopivat placebo dose on day 1 to day 23 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |