The Effect of Single Doses of the Motilin Receptor Agonist GSK962040 in Type I Diabetic Patients With Gastroparesis

Summary

The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis.

Timeline

Start

2009-06

Primary completion

2010-11

Completion

2010-11

Outcome

Met primary endpoint

paper Gastric half-emptying time decreased by -95 min (95% CI: -156.8, -34.2) after a single dose of camicinal 125 mg compared with placebo (52 vs. 147 min, P < 0.05), PMID 26924243 ↗

paper Camicinal significantly accelerated gastric emptying of solids in T1DM patients following administration of a single oral dose. PMID 26924243 ↗

Publications

• Hellstrom PM, Tack J, Johnson LV, Hacquoil K, Barton ME, Richards DB, Alpers DH, Sanger GJ, Dukes GE. The pharmacodynamics, safety and pharmacokinetics of single doses of the motilin agonist, camicinal, in type 1 diabetes mellitus with slow gastric emptying. Br J Pharmacol. 2016 Jun;173(11):1768-77. doi: 10.1111/bph.13475. Epub 2016 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	camicinal	Small molecule	25 mg	Oral
Subject	camicinal	Small molecule	50 mg	Oral
Subject	camicinal	Small molecule	125 mg	Oral

Indications