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• Status: Withdrawn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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Healthy male and female volunteers, 18 to 65 years of age, inclusive.

• A BMI between 18 to 30 kg/m2, inclusive.

• Healthy as determined by the Investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiogram (ECG)

• Female participants must use effective contraception as defined by the protocol and cannot be pregnant or breastfeeding

• Non-smoker or smoker of fewer than 10 cigarettes per day

• Must be able to refrain from smoking during the in-patient stay

Exclusion Criteria:

• Personal or family history of congenital long QT syndrome or family history of sudden death

• Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days prior to study start

• History of alcoholism, drug abuse or addiction within the last year prior to study start, or suspicion of drug abuse/addiction or alcohol use prior to study start

• Current alcohol consumption averaging more than 24 g of alcohol per day

• Any significant allergic reactions against any drug, or multiple allergies in the judgment of the Investigator