Skip to main content
OpenTrials
Completed

NCT Number: NCT01806415

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fenobam

Drug

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

Drug

Oral administration of placebo or lactose 150 mg

Other names: Lactose

Primary outcomes

  1. Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.

    Time frame: 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 outcomes

  1. Number of participants with adverse events as a measure of tolerability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 7, 2013
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.