A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.
Overview
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.
Full Title of Study: “A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE BITOPERTIN ON SINGLE DOSE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY VOLUNTEERS”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 31, 2014
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.
Arms, Groups and Cohorts
- Experimental: bitopertin-Midazolam
Clinical Trial Outcome Measures
Primary Measures
- Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
- Time Frame: Days 1 and 15
Secondary Measures
- Change in 1′-hydroxymidazolam plasma AUC after bitopertin administration
- Time Frame: Days 1 and 15
- Incidence of adverse events
- Time Frame: Approximately 76 days
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Hoffmann-La Roche
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Clinical Trials, Study Director, Hoffmann-La Roche
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