Clinical trial NCT01701739: A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration time curve
timeFrame: Approximately 1 month
measure: Pharmacokinetics: maximum plasma concentration
timeFrame: Approximately 1 month
Secondary outcomes:
measure: Pharmacokinetics: Elimination half-life
timeFrame: Approximately 1 month
measure: Pharmacokinetics: Time to maximum plasma concentration
timeFrame: Approximately 1 month
measure: Pharmacokinetics: Renal clearance
timeFrame: Approximately 1 month
measure: Pharmacokinetics: Apparent volume of distribution
timeFrame: Approximately 1 month
measure: Pharmacokinetics: Apparent clearance
timeFrame: Approximately 1 month
measure: Pharmacokinetics: Amount excreted in the urine
timeFrame: Approximately 1 month
measure: Pharmacokinetics: Fraction of drug excreted in urine
timeFrame: Approximately 1 month
measure: Safety: Incidence of adverse events
timeFrame: Approximately 2 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: