Beijing, 100083, China
NCT Number: NCT01711775
A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers
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.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
aleglitazar
DrugSingle oral dose Day 1, repeated oral dose once daily Days 5-14
Primary outcomes
-
Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)
Time frame: 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)
Time frame: Day 14 pre-dose and up to 24 hours post-dose
Secondary outcomes
-
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: 18 days
-
Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)
Time frame: up to 5 days
-
Single-dose pharmacokinetics: Half-life (t1/2)
Time frame: up to 5 days
-
Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: up to 5 days
-
Pharmacokinetics: Apparent oral plasma clearance (CL/F)
Time frame: 18 days
-
Pharmacokinetics: Apparent volume of distribution (VZ/F)
Time frame: 18 days
-
Pharmacokinetics: Accumulation index (Rac)
Time frame: 18 days
-
Safety: Incidence of adverse events
Time frame: approximately 10 months
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study 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
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 22, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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