A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: aleglitazar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aleglitazar<br> | Drug: aleglitazar<br>* Single oral dose Day 1, repeated oral dose once daily Days 5-14<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety: Incidence of adverse events |  | approximately 10 months |