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

NCT02019290 | Withdrawn Phase 1

• 1 other identifier: BP29245
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration

  Days 1 and 15

Secondary Outcomes (2)

• Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration

  Days 1 and 15

• Incidence of adverse events

  Approximately 76 days

Study Arms (1)

bitopertin-Midazolam

EXPERIMENTAL

Drug: Midazolam; Drug: bitopertin

Interventions

Midazolam DRUG

Single oral doses will be given on Days 1 and 15, after an overnight fast.

bitopertin-Midazolam

bitopertin DRUG

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.

bitopertin-Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Interventions

Midazolam; (4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: February 10, 2014
• Primary Completion: March 31, 2014
• Study Completion: March 31, 2014
• Last Updated: October 25, 2017

Record last verified: 2017-10