Clinical trial NCT01711775: A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)
timeFrame: Day 14 pre-dose and up to 24 hours post-dose
measure: Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)
timeFrame: Day 14 pre-dose and up to 24 hours post-dose
Secondary outcomes:
measure: Pharmacokinetics: Maximum concentration (Cmax)
timeFrame: 18 days
measure: Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)
timeFrame: up to 5 days
measure: Single-dose pharmacokinetics: Half-life (t1/2)
timeFrame: up to 5 days
measure: Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: up to 5 days
measure: Pharmacokinetics: Apparent oral plasma clearance (CL/F)
timeFrame: 18 days
measure: Pharmacokinetics: Apparent volume of distribution (VZ/F)
timeFrame: 18 days
measure: Pharmacokinetics: Accumulation index (Rac)
timeFrame: 18 days
measure: Safety: Incidence of adverse events
timeFrame: approximately 10 months
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: