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: August 4, 2014
Last verified: August 2014
  Purpose

This open-label study will assess the effects of hepatic impairment on the pharm acokinetics of a single oral dose of aleglitazar in subjects with mild or modera te 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 alegli tazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Antic ipated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014