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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: aleglitazar; Drug: digoxin

• Registration Number: NCT01701739
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aleglitazar / digoxin	aleglitazar	-
aleglitazar / digoxin	digoxin	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the concentration time curve	Approximately 1 month
Pharmacokinetics: maximum plasma concentration	Approximately 1 month

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Elimination half-life	Approximately 1 month
Pharmacokinetics: Renal clearance	Approximately 1 month
Pharmacokinetics: Time to maximum plasma concentration	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
Safety: Incidence of adverse events	Approximately 2 months
Pharmacokinetics: Fraction of drug excreted in urine	Approximately 1 month