Who is sponsoring NCT02483598?

NCT02483598 is sponsored by North Dakota State University.

What condition does NCT02483598 study?

NCT02483598 studies Gastric Bypass.

What drugs are being tested in NCT02483598?

Interventions: Buspirone, Buspirone and Grapefruit Juice.

What is the status of NCT02483598?

NCT02483598 is currently TERMINATED.

Last reviewed 2018-08-22 · How we verify

Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone

NCT02483598 Phase 4 TERMINATED

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.

Details

Lead sponsor	North Dakota State University
Phase	Phase 4
Status	TERMINATED
Enrolment	12
Start date	2015-06
Completion	2018-06

Conditions

Gastric Bypass

Interventions

Buspirone
Buspirone and Grapefruit Juice

Primary outcomes

Area-under-the-curve — 9-18 months following RYGB
The primary aim of this study is to compare the relative difference between the area-under-the-curve (AUC) of buspirone alone (buspirone) with the AUC of buspirone in the presence of grapefruit juice (buspirone + GFJ) in patients who underwent RYGB 9-18 months prior versus a control group of participants who have not undergone bariatric surgery.