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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02019290
• Other study ID #: BP29245
• Status: Withdrawn
• Phase: Phase 1
• First received: December 18, 2013
• Last updated: October 24, 2017
• Start date: February 10, 2014
• Est. completion date: March 31, 2014

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2014
• Est. primary completion date: March 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration		Days 1 and 15
Secondary	Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration		Days 1 and 15
Secondary	Incidence of adverse events		Approximately 76 days