A Phase 1 Study To Characterize The Safety, Tolerability, PK And PK Of Repeat Doses Of PF-06648671 In Healthy Adults And Healthy Elderly Subjects

Phase 1 Completed 92 enrolled Pfizer

RandomizedTriple-blindBasic science

Summary

This is an investigator-and-subject blind, phase 1 study to characterize the safety, tolerability, pharmacokinetics and central and peripheral pharmacodynamics of 14-day repeated ascending doses of PF-06648671 once a day in healthy adults (part 1) and repeated doses at the maximum tolerated dose (MTD) defined in part 1 in healthy elderly subjects (part 2). The study also include an optional cohort (part 3) to evaluate the drug interaction between PF-06648671 at MTD and CYP3A probe, midazolam

Timeline

Start: 2015-05
Primary completion: 2016-10
Completion: 2016-10

Publications

Ahn JE, Carrieri C, Dela Cruz F, Fullerton T, Hajos-Korcsok E, He P, Kantaridis C, Leurent C, Liu R, Mancuso J, Mendes da Costa L, Qiu R. Pharmacokinetic and Pharmacodynamic Effects of a gamma-Secretase Modulator, PF-06648671, on CSF Amyloid-beta Peptides in Randomized Phase I Studies. Clin Pharmacol Ther. 2020 Jan;107(1):211-220. doi: 10.1002/cpt.1570. Epub 2019 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	2 mg	Oral
Subject	PF-06648671	Small molecule	4 mg	Oral
Subject	PF-06648671	Small molecule	12 mg	Oral
Subject	PF-06648671	Small molecule	40 mg	Oral
Subject	PF-06648671	Small molecule	100 mg	Oral
Subject	PF-06648671	Small molecule	200 mg	Oral
Subject	PF-06648671	Small molecule	360 mg	Oral

Indications

No indication recorded.