NCT02875678

A Study to Evaluate the Effects of ABX-1431 on Patients With Functional Dyspepsia

A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients With Functional Dyspepsia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Abide Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Single-Dose Study to Evaluate the Effects of ABX-1431 on Gastric Accommodation and Nutrient Volume Tolerance in Patients with Functional Dyspepsia.

Detailed description

This is a single dose, randomized, placebo-controlled, two period crossover study. This study will assess the effects of ABX-1431 on gastric physiology in patients with functional dyspepsia, who have clinical evidence of impaired gastric accommodation with meals. All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with a single dose of ABX-1431 HCl or placebo followed by IGP measurement, measured with a high resolution manometry probe during a nutrient volume tolerance test. After a washout period of at least one week, patients will undergo identical procedures with the other treatment. This study will enroll 12 functional dyspepsia (FD) patients.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	ABX-1431	Single-dose ABX-1431
DRUG	Placebo	Single-dose matching placebo

Timeline

• Start date: 2016-11-22
• Primary completion: 2017-08-07
• Completion: 2017-08-07
• First posted: 2016-08-23
• Last updated: 2017-09-07

Locations

1 site across 1 country: Belgium