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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: digoxin; Drug: aleglitazar

Study type: Interventional

Funder types: Industry

Identifiers

NCT01701739

BP25562

2012-002269-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 1 patient group

aleglitazar / digoxin

Experimental group

Treatment:

Drug: digoxin

Drug: aleglitazar