Healthy Volunteer
Conditions
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.
Interventions
DRUGMidazolam
Single oral doses will be given on Days 1 and 15, after an overnight fast.
DRUGbitopertin
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration | Days 1 and 15 |
Secondary
| Measure | Time frame |
|---|---|
| Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration | Days 1 and 15 |
| Incidence of adverse events | Approximately 76 days |
Outcome results
None listed