Your session is about to expire
← Back to Search
Unknown
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 0 (pre-dose) on days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on day 10
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.
Eligible Conditions
- Liver disease
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hour 0 (pre-dose) on days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on day 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 0 (pre-dose) on days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on day 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600
Maximum Plasma Concentration (Cmax) for PF-06651600
Secondary study objectives
Number of Adverse Events Leading to Discontinuation
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Number of Participants With Out of Range Vital Signs
+1 moreSide effects data
From 2020 Phase 1 trial • 18 Patients • NCT0401607710%
Hepatic enzyme increased
10%
Headache
10%
Diarrhoea
10%
Cholestasis
10%
Thrombocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Moderate Hepatic Impairment
Normal Hepatic Function
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: PF-06651600 Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
This arm includes participants with moderate hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
Group II: PF-06651600 Mild Hepatic ImpairmentExperimental Treatment1 Intervention
This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met.
The arm includes participants with mild hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
Group III: PF-06651600 Healthy participantsExperimental Treatment1 Intervention
This arm includes healthy adult participants who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06651600
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,670 Previous Clinical Trials
17,826,869 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,867,771 Total Patients Enrolled