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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fenobam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18-50 yr old Good general health with no remarkable medical conditions (e.g liver, kidney, heart, or lung failure), BMI<33 and no known drug allergies. Willing to comply with study guidelines as outlined in protocol Willing to provide informed consent. Exclusion Criteria Medication use (prescription or non prescription medications, vitamins, herbals, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives) History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction) Pregnant or nursing female Lactose intolerance Smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenobam 50 mg<br>Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule. | Drug: Fenobam<br>* Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)<br>* Other names: N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea;|
| Experimental: Fenobam 100 mg<br>Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule. | Drug: Fenobam<br>* Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)<br>* Other names: N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea;|
| Experimental: Fenobam 150 mg<br>Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule. | Drug: Fenobam<br>* Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)<br>* Other names: N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea;|
| Placebo Comparator: Placebo arm<br>Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule. | Drug: Placebo<br>* Oral administration of placebo or lactose 150 mg<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals. | 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). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of tolerability | 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. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fenobam,, Pharmacokinetics, side effects