Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | September 2015 |
A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the 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.
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.
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.
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.
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
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