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

NCT ID: NCT01701739

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-01-31

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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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aleglitazar / digoxin

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

Multiple doses of aleglitazar

digoxin

Intervention Type DRUG

Single dose of digoxin

Interventions

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aleglitazar

Multiple doses of aleglitazar

Intervention Type DRUG

digoxin

Single dose of digoxin

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-002269-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP25562

Identifier Type: -

Identifier Source: org_study_id