A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711775
• Other study ID #: BP25230
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2012
• Last updated: November 1, 2016
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• aleglitazar
Single oral dose Day 1, repeated oral dose once daily Days 5-14

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)		Day 14 pre-dose and up to 24 hours post-dose	No
Primary	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	No
Secondary	Pharmacokinetics: Maximum concentration (Cmax)		18 days	No
Secondary	Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)		up to 5 days	No
Secondary	Single-dose pharmacokinetics: Half-life (t1/2)		up to 5 days	No
Secondary	Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)		up to 5 days	No
Secondary	Pharmacokinetics: Apparent oral plasma clearance (CL/F)		18 days	No
Secondary	Pharmacokinetics: Apparent volume of distribution (VZ/F)		18 days	No
Secondary	Pharmacokinetics: Accumulation index (Rac)		18 days	No
Secondary	Safety: Incidence of adverse events		approximately 10 months	No