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Completed

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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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing, 100083, China

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

Drug

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

Primary outcomes

  1. Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)

    Time frame: Day 14 pre-dose and up to 24 hours post-dose

  2. 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

  1. Pharmacokinetics: Maximum concentration (Cmax)

    Time frame: 18 days

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

    Time frame: up to 5 days

  3. Single-dose pharmacokinetics: Half-life (t1/2)

    Time frame: up to 5 days

  4. Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: up to 5 days

  5. Pharmacokinetics: Apparent oral plasma clearance (CL/F)

    Time frame: 18 days

  6. Pharmacokinetics: Apparent volume of distribution (VZ/F)

    Time frame: 18 days

  7. Pharmacokinetics: Accumulation index (Rac)

    Time frame: 18 days

  8. 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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