Trial intelligence / Profile preview

Buspirone PK and CYP3A4 Activity After RYGB

NCT02483598Phase 4

Key facts

Status
Terminated
Start
Jun 2015
Primary completion
Jun 2018
Sponsor
North Dakota State University
Modality
Small Molecules
Conditions
anxiety disorder
01

Overview

Phase 4, open-label trial of buspirone in anxiety disorder, sponsored by North Dakota State University. Primary endpoint: Area-under-the-curve. Started Jun 2015; status: terminated.

02

Design

Study design
Non-randomizedOpen-label
03

Who it enrols

Adults aged 18-65 who either underwent Roux-en-Y Gastric Bypass 9-18 months prior or are matched controls. Participants must be willing to consume grapefruit juice and have no contraindications to buspirone.

04

Endpoints

Primary

  • Area-under-the-curve

Secondary

  • Composite of pharmacokinetic measures

  • GLP-2 levels

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