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

NCT01197911 | Completed Phase 1 Results

• 1 other identifier: BP25240
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar

  AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

• Maximum Plasma Concentration (Cmax) of Aleglitazar

  Cmax was obtained directly from the concentration-time data.

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Secondary Outcomes (24)

• AUCinf of M1 (RO4408754) and M6 (RO4583746)

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

• Cmax of M1 and M6

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

• Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

• Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

• Apparent Total Body Clearance (CL/F) of Aleglitazar

  Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Study Arms (3)

Mild impairment

EXPERIMENTAL

Drug: aleglitazar

Moderate impairment

EXPERIMENTAL

Drug: aleglitazar

Normal HF

EXPERIMENTAL

Drug: aleglitazar

Interventions

aleglitazar DRUG

single oral dose

Mild impairment; Moderate impairment; Normal HF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

aleglitazar

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 24, 2015
• Results First Posted: December 24, 2015

Record last verified: 2015-11

Locations

US (2)