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

NCT ID: NCT01806415

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-09-30

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.

Conditions

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Healthy

Keywords

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Fenobam, Pharmacokinetics side effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fenobam 50 mg

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

Group Type EXPERIMENTAL

Fenobam

Intervention Type DRUG

Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)

Fenobam 100 mg

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

Group Type EXPERIMENTAL

Fenobam

Intervention Type DRUG

Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)

Fenobam 150 mg

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

Group Type EXPERIMENTAL

Fenobam

Intervention Type DRUG

Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)

Placebo arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of placebo or lactose 150 mg

Interventions

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Fenobam

Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)

Intervention Type DRUG

Placebo

Oral administration of placebo or lactose 150 mg

Intervention Type DRUG

Other Intervention Names

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N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea Lactose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Laura Cavallone

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Cavallone, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School Of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201304126

Identifier Type: -

Identifier Source: org_study_id