A Research Study of the Effect of Etavopivat on Other Drugs 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 a daily dose of etavopivat orally.
• Digoxin — DRUG
  Participants will receive a single dose of digoxin orally.
• Pitavastatin — DRUG
  Participants will receive a single dose of pitavastatin orally.
• Metformin — DRUG
  Participants will receive a single dose of metformin orally.
• Midazolam — DRUG
  Participants will receive a single dose of midazolam orally.
• Rosuvastatin — DRUG
  Participants will receive a single dose of rosuvastatin orally.

Study Details

The study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. The purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. During the study, participants will receive etavopivat and five different medicines that are already approved and available on the market, and which can be prescribed by doctors. These marketed medicines are called substrate drugs and they are: digoxin, pitavastatin, metformin, midazolam, and rosuvastatin. During a period of the study, participants will take 2 tablets of etavopivat daily for 10 consecutive days. The study will last for about 34 to 64 days.

Key Dates

Start date

Feb 6, 2025

Status verified

Sep 2025

Primary completion

May 27, 2025

Completion

May 27, 2025

Study Design

Enrollment

37 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Period 1: digoxin+pitavastatin+metformin
  Participants will receive a single dose of oral digoxin, pitavastatin and metformin.
• Experimental: Period 1: midazolam+rosuvastatin
  Participants will receive a single dose of oral midazolam and rosuvastatin.
• Experimental: Period 2: etavopivat+midazolam
  Participants will receive a daily dose of oral etavopivat and single dose of oral midazolam.
• Experimental: Period 2: etavopivat+midazolam+rosuvastatin
  Participants will receive a daily dose of oral etavopivat, single dose of oral midazolam and rosuvastatin.
• Experimental: Period 2: etavopivat+digoxin+pitavastatin+metformin
  Participants will receive a daily dose of oral etavopivat, single dose of oral digoxin, pitavastatin and metformin.

Primary Outcome Measure

Cmax, digoxin, SD: Maximum observed digoxin plasma concentration with and without etavopivat at steady state [ Time Frame: Day 1 and day 3 after digoxin administration ]

Locations (1)

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