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Completed

NCT Number: NCT00706537

Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

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.

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Key information

Conditions

Non-Alcoholic Steatohepatitis(NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Other forms than NASH liver disease.
  • Decompensated or severe liver disease.

Treatment and study plan

Active treatment

Drug

20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks

Placebo

Drug

Placebo as two tablets once daily for three weeks

Primary outcomes

  1. Urine 6-β-hydroxycortisol:cortisol ratio

    Time frame: 3 weeks

  2. Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.

    Time frame: 8 weeks

  3. PK for CP-945598 and its primary circulating metabolite

    Time frame: 6 weeks

Secondary outcomes

  1. Breath ID® tests (methacetin and octanoate)

    Time frame: 6 weeks

  2. Soluble and exploratory biomarkers

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 27, 2008
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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