Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers

Phase 1 Completed 97 enrolled Biogen

RandomizedParallel-groupDouble-blindBasic science

Summary

This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118

Timeline

Start: 2016-03-28
Primary completion: 2017-01-12
Completion: 2017-01-12

Publications

Lin J, Gaudreault F, Johnson N, Lin Z, Nouri P, Goosen TC, Sawant-Basak A. Investigation of CYP3A induction by PF-05251749 in early clinical development: comparison of linear slope physiologically based pharmacokinetic prediction and biomarker response. Clin Transl Sci. 2022 Sep;15(9):2184-2194. doi: 10.1111/cts.13352. Epub 2022 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BIIB118	Unknown	50 mg	Oral
Subject	BIIB118	Unknown	150 mg	Oral
Subject	BIIB118	Unknown	450 mg	Oral
Subject	BIIB118	Unknown	900 mg	Oral
Subject	Melatonin	Small molecule	—	—

Indications

No indication recorded.