A Research Study of the Effect of Food on Etavopivat in Healthy Participants
NCT06433661 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-10-10
Summary
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).
Conditions
- Healthy Volunteers Sickle Cell Disease, Thalassemia
Interventions
- DRUG
-
Etavopivat
Participants will receive single dose of oral Etavopivat in each treatment period.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-28
- Primary Completion
- 2024-07-06
- Completion
- 2024-07-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
NCT00586651 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People
NCT06291285 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
NCT05725902 ·Status: COMPLETED ·Phase: PHASE2
-
A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease
NCT01597401 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Oral Hydroxyurea Solution
NCT03763656 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A GBT021601 ADME Microtracer Study in Healthy Volunteers
NCT05718687 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare if the Uptake of Ticagrelor in the Body Differs When Different Tablets Are Administered
NCT03126695 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
NCT06612268 ·Status: RECRUITING ·Phase: PHASE3
-
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease
NCT02214121 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
NCT05861453 ·Status: COMPLETED ·Phase: PHASE2
-
A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301
NCT06363760 ·Status: ENROLLING_BY_INVITATION
-
Deferasirox BID (Twice a Day) in Transfusion Dependent Thalassemia Patients With Inadequate Response to High Doses
NCT01948817 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
NCT04610866 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet
NCT01430091 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease
NCT04055818 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).
NCT01090323 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects
NCT02497924 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease
NCT01987908 ·Status: TERMINATED ·Phase: PHASE2
-
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
NCT05675436 ·Status: ACTIVE_NOT_RECRUITING
-
A Dose-Finding Study of AG-348 in Sickle Cell Disease
NCT04000165 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke
NCT05953584 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
NCT03132324 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients
NCT05791591 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Oral GSK4172239D Compared With Placebo in Sickle Cell Disease Participants Aged 18 to 50 Years
NCT05660265 ·Status: TERMINATED ·Phase: PHASE1
-
Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions
NCT00067080 ·Status: COMPLETED ·Phase: PHASE2