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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Midazolam; Drug: bitopertin

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: bitopertin-Midazolam	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 10, 2014
• Primary Completion (ANTICIPATED): March 31, 2014
• Study Completion (ANTICIPATED): March 31, 2014

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (ESTIMATE): December 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: BP29245