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

NCT01679639 | Completed Phase 1

• 2 other identifiers: BP255612012-002274-31
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: Area under the plasma concentration time curve

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

Secondary Outcomes (1)

• Safety: incidence of adverse events

  14 weeks

Study Arms (1)

Aleglitazar

EXPERIMENTAL

Drug: aleglitazar; Drug: rifampicin

Interventions

aleglitazar DRUG

Single dose of aleglitazar in Periods 1, 2, 3

Aleglitazar

rifampicin DRUG

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

Aleglitazar

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

aleglitazar; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

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: September 1, 2012
• First Posted: September 6, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)