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Completed

NCT Number: NCT01679639

A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers

This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
  • Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
  • Females must be surgically sterile or use two acceptable methods of contraception
  • Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study

Exclusion criteria

  • Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
  • A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
  • Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • An average alcohol intake of more than 14 units per week
  • Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
  • Diagnosis of Gilberts Syndrome
  • A positive screen for drugs of abuse at screening or on admission to the clinical unit

Treatment and study plan

aleglitazar

Drug

Single dose of aleglitazar in Periods 1, 2, 3

rifampicin

Drug

Single dose in Periods 1 and 2; multiple doses in Period 3

Primary outcomes

  1. Pharmacokinetics: Area under the plasma concentration time curve

    Time frame: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12

Secondary outcomes

  1. Safety: incidence of adverse events

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 6, 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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