A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

A Single-center, Non-randomized, Open-label Study to Assess the Pharmacokinetics of Aleglitazar (RO0728804) After Administration of Single and Multiple Oral Doses of 150 µg Tablet in Healthy Chinese Subjects

This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: aleglitazar

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy female and male Chinese volunteers, 18 to 45 years of age inclusive at screening
• Subjects have to be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory measurements performed at screening
• Body mass index (BMI) 19 to 24 kg/m2 inclusive
• Female subjects who are not surgically sterile must be willing to use effective method of contraception as defined by protocol throughout the study and for 30 days after the last dosing

Exclusion Criteria:

• Any significant allergic reactions or multiple allergies
• Diagnosed or treated malignancy (except for treated cases of basal skin cancer or in situ carcinoma of the cervix) within the past 5 years
• Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
• Positive for hepatitis B, hepatitis C or HIV infection
• Any clinically relevant history of alcohol and/or other substance abuse or addiction within the last 2 years
• Pregnant or lactating women, or women who have a positive pregnancy test
• Regular smoker with consumption of more than 10 cigarettes per day or equivalent amount of tobacco
• Participation in an investigational drug or device study within 3 months prior to the first dosing

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aleglitazar	Drug: aleglitazar; Single oral dose Day 1, repeated oral dose once daily Days 5-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)	Day 14 pre-dose and up to 24 hours post-dose
Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)	Day 14 pre-dose and up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	approximately 10 months
Pharmacokinetics: Maximum concentration (Cmax)	18 days
Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)	up to 5 days
Single-dose pharmacokinetics: Half-life (t1/2)	up to 5 days
Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)	up to 5 days
Pharmacokinetics: Apparent oral plasma clearance (CL/F)	18 days
Pharmacokinetics: Apparent volume of distribution (VZ/F)	18 days
Pharmacokinetics: Accumulation index (Rac)	18 days

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (ESTIMATE): October 22, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP25230