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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: aleglitazar
* Drug: digoxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aleglitazar / digoxin<br> | Drug: aleglitazar<br>* Multiple doses of aleglitazar<br>Drug: digoxin<br>* Single dose of digoxin<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |