Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants

Phase 1 Terminated 61 enrolled Pfizer

RandomizedSequentialDouble-blindBasic science

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of single and multiple ascending oral doses of PF-07059013 in healthy adult participants. Additionally, effects of different formulations and food on parameters, including PK may be explored.

Timeline

Start: 2020-07-17
Primary completion: 2021-10-21
Completion: 2021-10-21

Outcome

Outcome not reported

Stopped: “Study was terminated as it did not demonstrate sufficient pharmacological effect. Termination was not related to safety reasons.”

Publications

Lee KC, Wan KX, Barricklow J, Lim CN, Clarke S, Potts D, Holmes K, Gonzalez P, Kavetska O. Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013. Bioanalysis. 2023 Sep;15(17):1083-1094. doi: 10.4155/bio-2023-0066. Epub 2023 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-07059013	Small molecule	—	Oral

Indications

No indication recorded.