A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: aleglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT01711775

BP25230

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 1 patient group

Aleglitazar

Experimental group

Treatment:

Drug: aleglitazar