MedTrace Logo

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

NCT04008186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-05-30

No results posted yet for this study

Summary

This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

Omaveloxolone

50 mg capsules

DRUG

Midazolam oral solution

2 mg/mL oral solution

DRUG

Repaglinide 1 MG

1 mg tablet

DRUG

MetFORMIN 500 Mg Oral Tablet

500 mg tablet

DRUG

Rosuvastatin

10 mg tablet

DRUG

Digoxin tablet

0.25 mg tablet

DRUG

Gemfibrozil Tablets

600 mg tablet

DRUG

Itraconazole capsule

100 mg capsule

DRUG

Verapamil Pill

120 mg tablet

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Jennifer Zon, MD · Covance CRU Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2019-08-18
Completion
2019-08-28
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 NCT04008186 on ClinicalTrials.gov