NCT01294566

FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers

Completed Phase 1 Last updated 28 June 2017

What this trial tests

Phase 1 trial testing GSK1322888 in Gastroparesis in 17 participants. Completed in 23 March 2011.

Timeline

29 November 2010

Primary endpoint
23 March 2011

23 March 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	17
Start date	29 November 2010
Primary completion	23 March 2011
Estimated completion	23 March 2011
Sites	1 location across Australia

Drugs / interventions tested

• GSK1322888 — full drug profile →
• Placebo

Conditions studied

• Gastroparesis — all drugs for Gastroparesis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Gastroparesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is the First Time In Human study for the motilin receptor agonist, GSK1322888. GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from the motilide compound structures. The aims of this study are to assess the safety, tolerance, and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in healthy volunteers.

The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.