Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fenobam; Drug: Placebo

• Registration Number: NCT01806415
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.

Detailed Description

Treatment regimen 1: Fenobam \[1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate\], oral administration of one 50 mg gelatin capsule.

Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.

Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.

Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.

Study Timeline

• Study First Submitted: 2013-03-02
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Study Start: 2013-05
• Primary Completion: 2014-03
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fenobam 100 mg	Fenobam	Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.
Placebo arm	Placebo	Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
Fenobam 50 mg	Fenobam	Treatment regimen 1: Fenobam \[1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate\], oral administration of one 50 mg gelatin capsule.
Fenobam 150 mg	Fenobam	Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.	24 hours	Blood samples will be drawn periodically before and after fenobam/placebo administration for approximately 10 hours (at approximately 30, 60, 120, 180, 240, 300, 360 and 600 minutes) and one more time the next day (day 2).

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of tolerability	1 week	Participants will be administered a questionnaire regarding side effects at the end of the study day, after administration of a single dose of 50 mg, 100 mg or 150 mg of fenobam, or 150 mg placebo. The questionnaire will be administered again the following day and one week after the study day. Side effects in the fenobam treatment groups will be compared to side effects in the placebo group.

Trial Locations

Locations (1)

Washington University School Of Medicine; 🇺🇸 St. Louis, Missouri, United States