Overview

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

Status:
Completed

Trial end date:
2013-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Digoxin

Criteria

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