Status:
COMPLETED
Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
Lead Sponsor:
Washington University School of Medicine
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 pharma...
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 adminis...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01806415
Start Date
May 1 2013
End Date
September 1 2015
Last Update
December 9 2015
Active Locations (1)
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1
Washington University School Of Medicine
St Louis, Missouri, United States, 63110