Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGaleglitazar
Single oral dose Day 1, repeated oral dose once daily Days 5-14
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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: Maximum concentration (Cmax) | 18 days |
| Pharmacokinetics: Accumulation index (Rac) | 18 days |
| Safety: Incidence of adverse events | approximately 10 months |
| Pharmacokinetics: Apparent volume of distribution (VZ/F) | 18 days |
| Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax) | up to 5 days |
Countries
China
Outcome results
None listed