drugset / Trial / NCT02483598
Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone
Phase 4
Terminated
12 enrolled
North Dakota State University
Neuropsychiatric Research Institute, Fargo, North Dakota · collab
RandomizedCrossoverOpen-labelOther
Summary
This study is to compare intestinal Cytochrome P450 3A4 (CYP3A4) activity in 9-18 month post weight loss surgery Roux-en-Y Gastric Bypass (RYGB) versus control subjects who have not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass group. For this purpose, we will compare post-bariatric surgery patients with control subjects on alterations in systemic exposure of buspirone, a CYP3A4 substrate, when administered with grapefruit juice, a selective intestinal CYP3A4 inhibitor.
Timeline
- Start
- 2015-06
- Primary completion
- 2018-06
- Completion
- 2018-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buspirone | Small molecule | — | — |
| Subject | Grapefruit Juice | Unknown | — | — |
Indications
No indication recorded.