A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162

Phase 1 Completed 10 enrolled Pfizer

RandomizedParallel-groupDouble-blindBasic science

Summary

The purpose of this study in healthy people is to investigate safety, toleration and time course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162 will also be investigated.

Timeline

Start: 2012-10
Primary completion: 2013-03
Completion: 2013-03

Publications

Generaux G, Lakhani VV, Yang Y, Nadanaciva S, Qiu L, Riccardi K, Di L, Howell BA, Siler SQ, Watkins PB, Barton HA, Aleo MD, Shoda LKM. Quantitative systems toxicology (QST) reproduces species differences in PF-04895162 liver safety due to combined mitochondrial and bile acid toxicity. Pharmacol Res Perspect. 2019 Oct 9;7(6):e00523. doi: 10.1002/prp2.523. eCollection 2019 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-04895162	Unknown	300 mg	Oral

Indications

No indication recorded.