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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01806415

Run by

Washington University School of Medicine

People needed

32

Starts

2013-05-01

Expected to finish

2015-09-01

Last updated by the study team

2015-12-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

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

Where it is running

• Washington University School Of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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