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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01701739

Enrollment

Registered

2012-10-05

Start date

2012-10-31

Completion date

2013-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGaleglitazar

Multiple doses of aleglitazar

DRUGdigoxin

Single dose of digoxin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026