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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00706537

Enrollment

Registered

2008-06-27

Start date

2008-07-31

Completion date

2008-11-30

Last updated

2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Steatohepatitis(NASH)

Keywords

Pharmacokinetic safety NASH patients

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.

Interventions

DRUGActive treatment

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

DRUGPlacebo

Placebo as two tablets once daily for three weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Breath ID® tests (methacetin and octanoate)	6 weeks
Soluble and exploratory biomarkers	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026