CLINICAL TRIALS PROFILE FOR PF-05221304

Clinical Trials for PF-05221304

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02871037 ↗	Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects	Completed	Pfizer	Phase 1	The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.
NCT03248882 ↗	Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)	Completed	Pfizer	Phase 2	Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03309202 ↗	Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment	Completed	Pfizer	Phase 1	Hepatic impairment PK study
NCT03448172 ↗	Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects	Completed	Pfizer	Phase 1	The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
NCT03534648 ↗	Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects	Completed	Pfizer	Phase 1	Drug drug interaction study between PF-05221304 and PF-06865571
NCT03597217 ↗	A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults	Completed	Pfizer	Phase 1	The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.
NCT03776175 ↗	A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.	Completed	Pfizer	Phase 2	This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD. In addition, this study will evaluate the safety and tolerability of co administration of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571 alone, and placebo in adults with NAFLD.

Clinical Trial Conditions for PF-05221304

Condition Name

Condition Name for
Intervention	Trials
Healthy	4
Nonalcoholic Fatty Liver Disease	3
Nonalcoholic Steatohepatitis	2
NAFLD (Nonalcoholic Fatty Liver Disease)	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Liver Diseases	6
Fatty Liver	5
Non-alcoholic Fatty Liver Disease	5
Liver Cirrhosis	1

Clinical Trial Locations for PF-05221304

Trials by Country

Trials by Country for
Location	Trials
United States	71
Canada	15
Japan	12
China	10
India	6

Trials by US State

Trials by US State for
Location	Trials
Florida	5
Virginia	4
Texas	4
Ohio	4
New York	4

Clinical Trial Progress for PF-05221304

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	4
Phase 1	7

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	8
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for PF-05221304

Sponsor Name

Sponsor Name for
Sponsor	Trials
Pfizer	11
Columbia University	1
Henry N. Ginsberg	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	11
Other	2