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

NCT ID: NCT02019290

Last Updated: 2017-10-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-10
• Study Completion Date: 2014-03-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bitopertin-Midazolam

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

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

bitopertin

Intervention Type: DRUG

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.

Interventions

Midazolam

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

France

Other Identifiers

BP29245

Identifier Type: -

Identifier Source: org_study_id