A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.
- Registration Number
- NCT02019290
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description bitopertin-Midazolam Midazolam - bitopertin-Midazolam bitopertin -
- Primary Outcome Measures
Name Time Method Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration Days 1 and 15
- Secondary Outcome Measures
Name Time Method Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration Days 1 and 15 Incidence of adverse events Approximately 76 days