Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
A Multiple Dose, Randomized, Double-Blind (3rd Party Open), Placebo-Controlled Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of CP-945598 In Subjects With Nonalcoholic Steatohepatitis (NASH)
1 other identifier
interventional
9
1 country
3
Brief Summary
CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safety of this compound prior to any further studies in NASH patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2008
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedAugust 13, 2009
November 1, 2008
4 months
June 25, 2008
August 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Urine 6-β-hydroxycortisol:cortisol ratio
3 weeks
Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.
8 weeks
PK for CP-945598 and its primary circulating metabolite
6 weeks
Secondary Outcomes (2)
Breath ID® tests (methacetin and octanoate)
6 weeks
Soluble and exploratory biomarkers
3 weeks
Study Arms (2)
CP-945598 20 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) of 25 to 40 kg/m2
- Subjects with biopsy evidence of NASH in the 2 years prior to the screening visit.
- Hemoglobin ≥11 g/dL, platelet count ≥100,000 cells/mm3, neutrophil count ≥1,500cells/mm3.
You may not qualify if:
- Other forms than NASH liver disease.
- Decompensated or severe liver disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Pfizer Investigational Site
Anaheim, California, 92801, United States
Pfizer Investigational Site
Anaheim, California, 92804, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2008
First Posted
June 27, 2008
Study Start
July 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
August 13, 2009
Record last verified: 2008-11