A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

NCT01711775 | Completed Phase 1

• 1 other identifier: BP25230
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pharmacokinetics: Maximum concentration (Cmax)

  18 days

• Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)

  up to 5 days

• 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

Study Arms (1)

Aleglitazar

EXPERIMENTAL

Drug: aleglitazar

Interventions

aleglitazar DRUG

Single oral dose Day 1, repeated oral dose once daily Days 5-14

Aleglitazar

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Beijing, 100083, China

Location

MeSH Terms

Interventions

aleglitazar

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CN (1)