| Trial ID: | L0991 |
| Source ID: | NCT04091061
|
| Associated Drug: |
PF-06865571
|
| Title: |
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT04091061/results
|
| Conditions: |
Hepatic Impairment|Healthy Volunteers
|
| Interventions: |
Drug: PF-06865571 100 mg
|
| Outcome Measures: |
Maximum Observed Plasma Concentration (Cmax)|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)|Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Number of Participants With Clinical Laboratory Abnormalities|Number of Participants With Categorical Vital Signs Data|Number of Participants With Categorical Electrocardiogram (ECG)
|
| Sponsor/Collaborators: |
Pfizer
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
24
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
|
| Start Date: |
October 3, 2019
|
| Completion Date: |
April 7, 2020
|
| Results First Posted: |
April 13, 2021
|
| Last Update Posted: |
April 13, 2021
|
| Locations: |
University of Miami Division of Clinical Pharmacology, Miami, Florida, United States|Orlando Clinical Research Center, Orlando, Florida, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04091061
|
