Overview

A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.

Status:
Withdrawn

Trial end date:
2014-03-31

Target enrollment:

Participant gender:

Summary

This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers. A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast. Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.

Phase:

Phase 1

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Midazolam