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Sponsor: Hoffmann-La Roche
Conditions: Healthy Volunteer
Interventions: Midazolam, bitopertin
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
Age: 18 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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