Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

Phase 1 Completed 26 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Timeline

Start: 2010-12
Primary completion: 2011-06
Completion: 2011-06

Publications

Cobbina E, Lee MR, Leggio L, Akhlaghi F. A Population Pharmacokinetic Analysis of PF-5190457, a Novel Ghrelin Receptor Inverse Agonist in Healthy Volunteers and in Heavy Alcohol Drinkers. Clin Pharmacokinet. 2021 Apr;60(4):471-484. doi: 10.1007/s40262-020-00942-7. Epub 2020 Nov 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-5190457	Small molecule	2 mg	Oral
Subject	PF-5190457	Small molecule	10 mg	Oral
Subject	PF-5190457	Small molecule	30 mg	Oral
Subject	PF-5190457	Small molecule	100 mg	Oral
Subject	PF-5190457	Small molecule	300 mg	Oral
Subject	PF-5190457	Small molecule	600 mg	Oral

Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications