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

NCT02019290 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-10-25

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Midazolam

Single oral doses will be given on Days 1 and 15, after an overnight fast.

DRUG

bitopertin

An oral dose will be given daily in the morning from Days 2-15. On Days 14 and 15, bitopertin will be given after an overnight fast; on Days 2-13, bitopertin will be given under fed conditions.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-02-10
Primary Completion
2014-03-31
Completion
2014-03-31

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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 NCT02019290 on ClinicalTrials.gov