A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Novo Nordisk A/S
Study ID
NCT07023029
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Etavopivat — DRUG
    Etavopivat will be administered orally.
  • Moxifloxacin — DRUG
    Moxifloxacin will be administered orally.
  • Placebo — DRUG
    Placebo matching Etavopivat will be administered orally.

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
Dec 2025
Primary completion
Sep 12, 2025
Completion
Sep 22, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A- Etavopivat
    Participants will receive a single dose of etavopivat.
  • Placebo Comparator: Part A- Placebo
    Participants will receive a single dose of placebo.
  • Experimental: Part B- Etavopivat
    Participants will receive a single dose of etavopivat.
  • Other: Part B- Moxifloxacin
    Participants will receive a single dose of moxifloxacin.
  • Placebo Comparator: Part B- Placebo
    Participants will receive a single dose of placebo.

Primary Outcome Measure

Part A: Number of treatment-emergent adverse events (AEs) [ Time Frame: From dosing (Day 1) until end of study (Day 8) ]

Locations (1)

FacilityCityStateZIPSite coordinators
PAREXEL Intl - EPCU-BaltimoreBaltimoreMaryland21225-

Find similar trials in Baltimore, MD

By condition
Sickle cell disease
By research site
PAREXEL Intl - EPCU-Baltimore· Baltimore, MD

Related Studies