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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Midazolam
* Drug: bitopertin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bitopertin-Midazolam<br> | Drug: Midazolam<br>* Single oral doses will be given on Days 1 and 15, after an overnight fast.<br>Drug: bitopertin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration |  | Days 1 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration |  | Days 1 and 15 | 
| Incidence of adverse events |  | Approximately 76 days |