A Research Study of the Effect of Food on Etavopivat in Healthy Participants

Conditions

• Healthy Volunteers Sickle Cell Disease, Thalassemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Etavopivat — DRUG
  Participants will receive single dose of oral Etavopivat in each treatment period.

Study Details

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).

Key Dates

Start date

May 28, 2024

Status verified

Oct 2025

Primary completion

Jul 6, 2024

Completion

Jul 8, 2024

Study Design

Enrollment

16 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Sequence 1: Etavopivat: fed-fasted
  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.
• Experimental: Sequence 2: Etavopivat: fasted-fed
  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.

Primary Outcome Measure

AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose [ Time Frame: From 0 to 120 hours after IMP administration (V2/V6) ]

Locations (1)

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