Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00969813

Hepatic Insufficiency

COMPLETED PHASE1

A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems

NCT06957756

Hepatic Insufficiency

RECRUITING PHASE1

Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency

NCT01916993

Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects

COMPLETED PHASE1

Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment

NCT02120547

Liver Insufficiency

COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment

NCT05481411

Hepatic Impairment

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Hepatic Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild hepatic function

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Administration of CP-945,598 in subjects with mild hepatic function

Moderate hepatic function

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Administration of CP-945,598 in subjects with moderate hepatic function

Normal hepatic function

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Administration of CP-945,598 in subjects with normal hepatic function

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CP-945,598

Administration of CP-945,598 in subjects with mild hepatic function

Intervention Type DRUG

CP-945,598

Administration of CP-945,598 in subjects with moderate hepatic function

Intervention Type DRUG

CP-945,598

Administration of CP-945,598 in subjects with normal hepatic function

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
* Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.

Exclusion Criteria

* All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
* Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
* Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes