Effect of ATI-7505 on Gastrointestinal Transit in Healthy Volunteers

Phase 1/2 Completed 48 enrolled Mayo Clinic ARYx Therapeutics · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a pharmacodynamic study in healthy volunteers to determine the effects of a new 5-HT4 agonist on gastric, small bowel and colonic transit.

Timeline

Start: 2005-01
Primary completion: 2005-12
Completion: 2005-12

Outcome

Mixed primary results

paper Primary endpoints were gastric-emptying (GE) T(1/2), colonic geometric centre (GC) at 24 h and ascending colon (AC) emptying T(1/2). PMID 17187586 ↗

paper There were borderline overall treatment effects (decrease) on GE T(1/2) (P = 0.154); PMID 17187586 ↗

paper ATI-7505 increased colonic transit (GC24, P = 0.031) PMID 17187586 ↗

paper ATI-7505 accelerated AC emptying T(1/2) (overall P = 0.075) PMID 17187586 ↗

Publications

Results Camilleri M, Vazquez-Roque MI, Burton D, Ford T, McKinzie S, Zinsmeister AR, Druzgala P. Pharmacodynamic effects of a novel prokinetic 5-HT receptor agonist, ATI-7505, in humans. Neurogastroenterol Motil. 2007 Jan;19(1):30-8. doi: 10.1111/j.1365-2982.2006.00865.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ATI-7505	Unknown	3 mg	—
Subject	ATI-7505	Unknown	10 mg	—
Subject	ATI-7505	Unknown	20 mg	—

Indications

No indication recorded.