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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02019290
Other study ID # BP29245
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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