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

Primary Purpose

Non-Alcoholic Steatohepatitis(NASH)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Active treatment

Placebo

About this trial

This is an interventional basic science trial for Non-Alcoholic Steatohepatitis(NASH) focused on measuring Pharmacokinetic safety NASH patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CP-945598 20 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Urine 6-β-hydroxycortisol:cortisol ratio

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

PK for CP-945598 and its primary circulating metabolite

Secondary Outcome Measures

Breath ID® tests (methacetin and octanoate)

Soluble and exploratory biomarkers

Full Information

NCT ID

NCT00706537

First Posted

June 25, 2008

Last Updated

August 11, 2009

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00706537

Brief Title

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

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Steatohepatitis(NASH)

Keywords

Pharmacokinetic safety NASH patients

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CP-945598 20 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Active treatment

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo as two tablets once daily for three weeks

Primary Outcome Measure Information:

Title

Urine 6-β-hydroxycortisol:cortisol ratio

Time Frame

3 weeks

Title

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

Time Frame

8 weeks

Title

PK for CP-945598 and its primary circulating metabolite

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Breath ID® tests (methacetin and octanoate)

Time Frame

6 weeks

Title

Soluble and exploratory biomarkers

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

Pfizer Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5351053&StudyName=Phase%201%20Pharmacokinetic%20Study%20Of%20CP-945598%20In%20Patients%20With%20NASH

Description

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

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