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A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
Sponsor: Sanofi
Summary
This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
Official title: A Phase 1, Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled, 4-period Crossover Study to Evaluate the Effect of a Single Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-12-04
Completion Date
2026-04-27
Last Updated
2026-01-13
Healthy Volunteers
Yes
Conditions
Interventions
Balinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
Moxifloxacin
Pharmaceutical form: Tablet Route of administration: Oral
Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Locations (2)
FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400002
Dallas, Texas, United States
FORTREA CLINICAL RESEARCH UNIT INC- Site Number : 8400001
Madison, Wisconsin, United States