Healthy
Conditions
Keywords
Fenobam,, Pharmacokinetics, side effects
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.
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 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.
Interventions
DRUGFenobam
Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)
DRUGPlacebo
Oral administration of placebo or lactose 150 mg
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of tolerability | 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. |
Countries
United States
Outcome results
None listed