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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fenobam; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01806415

201304126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. 18-50 yr old
2. Good general health with no remarkable medical conditions (e.g liver, kidney, heart, or lung failure), BMI<33 and no known drug allergies.
3. Willing to comply with study guidelines as outlined in protocol
4. Willing to provide informed consent.

Exclusion Criteria

1. 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)
2. History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
3. Pregnant or nursing female
4. Lactose intolerance
5. Smokers

Trial design

32 participants in 4 patient groups, including a placebo group

Fenobam 50 mg

Experimental group

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:

Drug: Fenobam

Fenobam 100 mg

Experimental group

Description:

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

Treatment:

Drug: Fenobam

Fenobam 150 mg

Experimental group

Description:

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

Treatment:

Drug: Fenobam

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo