A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01197911
First received: September 8, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.


Condition Intervention Phase
Healthy Volunteer
Drug: aleglitazar
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Hepatic Impairment on the Pharmacokinetics of Aleglitazar: A Multiple-centre, Open-label Study Following a Single Oral Dose of Aleglitazar to Subjects With Mild or Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effects of mild and moderate hepatic impairment on the pharmacokinetics (AUCinf, Cmax) of aleglitazar following a single oral dose [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability in subjects with mild and moderate hepatic impairment following a single oral dose: Adverse events, ECG, vital signs, laboratory parameters [ Time Frame: from baseline to Day 10 (+/- 1) ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal HF Drug: aleglitazar
single oral dose
Experimental: Mild impairment Drug: aleglitazar
single oral dose
Experimental: Moderate impairment Drug: aleglitazar
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adults, 18-70 years of age inclusive
  • Normal hepatic function or mild to moderate impaired liver function (Child-Pugh class A or B)
  • Body mass index (BMI) 18 to 40 kg/m2 inclusive
  • Females must be either surgically sterile, postmenopausal, or willing to use two reliable methods of contraception for the duration of the study and started 3 months before study start

Exclusion Criteria:

  • For subjects with hepatic impairment: evidence of progressive liver disease within the last 4 weeks, or biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease
  • For healthy volunteers: positive test for hepatitis B or C, alcohol intake of more than 14 units per week, or history of clinically significant alcohol or drug abuse
  • Acute infection or current malignancy requiring treatment
  • History of clinically significant allergic disease or drug hypersensitivity
  • Positive test for HIV-1 or HIV-2 at screening
  • Participation in a clinical study with an investigational drug or new chemical entity within 2 months prior to screening
  • Females who are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197911

Locations
United States, Florida
Orlando, Florida, United States, 32809
United States, Tennessee
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01197911     History of Changes
Other Study ID Numbers: BP25240
Study First Received: September 8, 2010
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014