NCT00562848

A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040

A First-Time-in-Human Randomized Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of the Oral Motilin Receptor Agonist GSK962040, in Male and Female Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Motilin is a peptide whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore provide a potential approach to the treatment of a range of clinical conditions where delayed gastric emptying may contribute to symptoms, such as enteral feeding intolerance (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and functional dyspepsia. This study is the First Time In Human study for the motilin receptor agonist, GSK962040.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	GSK962040	GSK962040 will be supplied in the following tablet strengths: 1 milligram, 5m milligrams, 25 milligrams, 125 milligrams.
DRUG	Placebo	Subjects will receive placebo.

Timeline

• Start date: 2007-09-10
• Primary completion: 2008-06-27
• Completion: 2008-06-27
• First posted: 2007-11-22
• Last updated: 2017-08-08

Locations

1 site across 1 country: Belgium