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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Fenobam 100 mg | Experimental | Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule. |
|
| Fenobam 150 mg | Experimental | Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule. |
|
| Placebo arm | Placebo Comparator | Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenobam | Drug | Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of tolerability | 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Laura Cavallone, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| C032794 | fenobam |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo | Drug | Oral administration of placebo or lactose 150 mg |
|
|
| 1 week |
| D000073893 |
| Sugars |