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PF-06651600 Moderate Hepatic Impairment for Healthy Subjects

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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Side effects data

From 2020 Phase 1 trial • 18 Patients • NCT04016077
10%
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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,407 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,583 Total Patients Enrolled
~3 spots leftby Nov 2025
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