To Study the Effect of Cenerimod on the Electrical Activity of the Heart, in Men and Women. To Study the Effect of Cenerimod on the Use of Oral Contraceptives in Women. To Study the Effect That Charcoal Has on the Elimination of Cenerimod From the Body, in Women and Men.

Healthy Subjects Clinical Trial

Official title: A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.

Status Completed

Clinical Trial Summary

This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants. Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.

Clinical Trial Description

Participants randomized in one of the cenerimod or placebo groups will receive combined oral contraceptives on Day 1 (i.e., prior to cenerimod or placebo administration, Period 1) and on Day 42 (i.e., 36 days after the stat of cenerimod or placebo, Period 2). Half of the participants randomized in one of the cenerimod or placebo groups will be enrolled in an accelerated elimination procedure part (Period 3). ;

Related Conditions & MeSH terms

• Healthy Subjects

• NCT number: NCT04255277
• Study type: Interventional
• Source: Idorsia Pharmaceuticals Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2020
• Completion date: October 18, 2021