| Trial ID: | L0990 |
| Source ID: | NCT04193436
|
| Associated Drug: |
PF-06835919
|
| Title: |
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Hepatic Impairment|Healthy Participants
|
| Interventions: |
Drug: PF-06835919 25 mg
|
| Outcome Measures: |
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[inf])|Maximum Plasma Concentration (C[max])|Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[inf,u])|Unbound Maximum Plasma Concentration (C[max,u])|Fraction of Drug Unbound (f[u])|Number of Participantss Reporting Treatment-emergent AEs|Number of Participants with Clinically Significant Change from Baseline in Laboratory Tests|Number of Participants with Clinically Significant Change from Baseline in Vital Signs|Njumber of Participants with Clinically Significant Change from Baseline in 12-Lead ECGs
|
| Sponsor/Collaborators: |
Pfizer
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
23
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
|
| Start Date: |
January 21, 2020
|
| Completion Date: |
July 9, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 12, 2021
|
| Locations: |
Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, R??gion DE, Belgium|Pharmaceutical Research Associates CZ, s.r.o., Praha 7, Czechia|Summit Clinical Research, s.r.o.,, Bratislava, Slovakia
|
| URL: |
https://ClinicalTrials.gov/show/NCT04193436
|
