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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2014

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: bitopertin-Midazolam

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in 1′-hydroxymidazolam plasma AUC after bitopertin administration
    • Time Frame: Days 1 and 15
  • Incidence of adverse events
    • Time Frame: Approximately 76 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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