Phase 1
Completed N=18
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
hepatic impairment · Healthy Participants
Source: ClinicalTrials.gov NCT04016077 ↗
Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Apr 2021
Primary outcomePrimary: Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600 — 454.5; 383.6 nanogram*hour per milliliter (ng*hr/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600 |
454.5; 383.6 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) for PF-06651600 |
194.3; 186.9 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) |
4; 2; 4; 1; 1; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
9; 2 | — |
| SECONDARY Number of Participants With Out of Range Vital Signs |
1; 0 | — |
| SECONDARY Number of Adverse Events Leading to Discontinuation |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures
- Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb)
Additional Inclusion Criteria for Participants with Normal Hepatic Function:
- Healthy male or female participants
- No known or suspected hepatic disease
Additional Inclusion Criteria for Participants with Impaired Hepatic Function:
- Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days prior to the Screening visit
- No other ongoing clinically significant abnormalities based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except for the abnormal findings that are related to the participant's hepatic impairment.
- Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild: Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28 days of investigational product administration.
Exclusion Criteria
- Has active acute or chronic infection requiring treatment or history of systemic infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis
- Infection with hepatitis B, hepatitis C or HIV
- Any condition affecting drug absorption, distribution, metabolism and excretion (eg, status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal resection)
- Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed per protocol
Additional Exclusion Criteria for Participants with Normal Hepatic Function:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease
Additional Exclusion Criteria for Participants with Impaired Hepatic Function:
- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score >9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol
Data sourced from ClinicalTrials.gov (NCT04016077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.