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

Roche

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Midazolam; Drug: bitopertin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02019290

BP29245

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

bitopertin-Midazolam

Experimental group

Treatment:

Drug: bitopertin

Drug: Midazolam