A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers

An Open-label, Two-period Fixed-sequence Study to Investigate the Effect of Multiple Doses of Aleglitazar on a Single Dose of Digoxin in Healthy Subjects

This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on study treatment is one month.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: aleglitazar; Drug: digoxin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers, 18-55 years of age, inclusive
• Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
• Females must be either surgically sterile or post-menopausal for at least one year or, if they are of child-bearing potential, must use two acceptable methods of contracepetion
• Volunteer normally drinks no more than three cups of coffee/tea/caffeinated soft drinks per day and is willing to stop drinking coffee/tea/caffeinated soft drinks during the study

Exclusion Criteria:

• Any clinically relevant abnormal laboratory test results at screening or on Day -1
• Has taken any prescribed or herbal/over the counter medication within 2 weeks prior to the first dosing
• A history of clinically significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary or neurological conditions or lipid metabolism disorders.
• Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C
• An average alcohol intake of more than 14 units per week
• A known permanent or unexplained elevation of serum transaminases > 1.5 times the upper limit of normal
• A positive screen for drugs of abuse
• Acute infection requiring treatment within 4 weeks prior to screening
• Diagnosed or treated malignancy within the past 5 years

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aleglitazar / digoxin	Drug: aleglitazar; Multiple doses of aleglitazar; Drug: digoxin; Single dose of digoxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Area under the concentration time curve	Approximately 1 month
Pharmacokinetics: maximum plasma concentration	Approximately 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Elimination half-life	Approximately 1 month
Pharmacokinetics: Time to maximum plasma concentration	Approximately 1 month
Pharmacokinetics: Renal clearance	Approximately 1 month
Pharmacokinetics: Apparent volume of distribution	Approximately 1 month
Pharmacokinetics: Apparent clearance	Approximately 1 month
Pharmacokinetics: Amount excreted in the urine	Approximately 1 month
Pharmacokinetics: Fraction of drug excreted in urine	Approximately 1 month
Safety: Incidence of adverse events	Approximately 2 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 5, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: BP25562; 2012-002269-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No