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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01806415
Collaborator
(none)
32
Enrollment
1
Location
4
Arms
28
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Official Title:
A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Fenobam
Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)
Other Names:
  • N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea

    		•
    Experimental: Fenobam 100 mg

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

    Drug: Fenobam
    Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)
    Other Names:
  • N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea

    		•
    Experimental: Fenobam 150 mg

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

    Drug: Fenobam
    Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)
    Other Names:
  • N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea

    		•
    Placebo Comparator: Placebo arm

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

    Drug: Placebo
    Oral administration of placebo or lactose 150 mg
    Other Names:
  • Lactose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School Of Medicine St. Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Laura Cavallone, MD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laura Cavallone, Assistant Professor of Anesthesiology, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01806415
    Other Study ID Numbers:
    • 201304126
    First Posted:
    Mar 7, 2013
    Last Update Posted:
    Dec 9, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Laura Cavallone, Assistant Professor of Anesthesiology, Washington University School of Medicine
    Fenobam,
    Pharmacokinetics
    side effects
    Additional relevant MeSH terms:
    Imidazole

    Study Results

    No Results Posted as of Dec 9, 2015