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A TQTc Study for Omaveloxolone

NCT05927649 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-30

No results posted yet for this study

Summary

This is a randomized, double blind, placebo and active (moxifloxacin open label) controlled study in healthy subjects to assess the effect of the supratherapeutic exposure of omaveloxolone on QTc interval. Moxifloxacin will be used as an active control and will be administered as open label. Omaveloxolone and placebo will be administered in a blinded fashion. All treatments will be administered after an FDA high-fat meal. Concentration-QTc (C-QTc) analysis is the primary analysis for the study.

Conditions

  • Health Adult Subjects

Interventions

DRUG

Omaveloxolone

Omaveloxolone capsules

DRUG

Moxifloxacin

Moxifloxacin capsules

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Q2 Solutions

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Michelle Valentine, DO · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05927649 on ClinicalTrials.gov