A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function

• ClinicalTrials.gov Identifier: NCT00969813
• Recruitment Status: Completed
• First Posted: September 1, 2009
• Last Update Posted: February 11, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 31, 2009
• First Posted Date: September 1, 2009
• Last Update Posted Date: February 11, 2010
• Study Start Date: November 2009
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2009): Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function [ Time Frame: 3 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 31, 2009): Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function [ Time Frame: 10-14 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
• Official Title: A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
• Brief Summary: This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
• Condition: Hepatic Insufficiency

Intervention

Drug: CP-690,550

Single 10 mg dose of CP-690,550

Study Arms

• Experimental: Normal hepatic function
  Intervention: Drug: CP-690,550
• Experimental: Mild hepatic impairment
  Intervention: Drug: CP-690,550
• Experimental: Moderate hepatic impairment
  Intervention: Drug: CP-690,550

• Publications *: Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1. Erratum in: Clin Pharmacol Drug Dev. 2018 Feb;7(2):222.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2010): 18
• Original Estimated Enrollment (submitted: August 31, 2009): 30
• Actual Study Completion Date: January 2010
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.

Exclusion Criteria:

• Subjects with severe liver impairment
• Subjects who have weakened immune systems

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00969813
• Other Study ID Numbers: A3921015
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2010