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

NCT01806415 | Completed Phase 1 DMC

• 1 other identifier: 201304126
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Fenobam,; Pharmacokinetics; side effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with adverse events as a measure of tolerability

  1 week

Study Arms (4)

Fenobam 50 mg

EXPERIMENTAL

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

Fenobam 100 mg

EXPERIMENTAL

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

Drug: Fenobam

Fenobam 150 mg

EXPERIMENTAL

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

Drug: Fenobam

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fenobam DRUG

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

Also known as: N-(3-chlorophenyl)-N'-(4,5-dihydro-1-methyl-4-oxo-1H-imidazole-2-yl)urea

Fenobam 100 mg; Fenobam 150 mg; Fenobam 50 mg

Placebo DRUG

Oral administration of placebo or lactose 150 mg

Also known as: Lactose

Placebo arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

fenobam; Lactose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Laura Cavallone, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: March 2, 2013
• First Posted: March 7, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

US (1)