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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701739
• Other study ID #: BP25562
• Secondary ID: 2012-002269-36
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2012
• Last updated: November 1, 2016
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• aleglitazar
Multiple doses of aleglitazar
• digoxin
Single dose of digoxin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration time curve		Approximately 1 month	No
Primary	Pharmacokinetics: maximum plasma concentration		Approximately 1 month	No
Secondary	Pharmacokinetics: Elimination half-life		Approximately 1 month	No
Secondary	Pharmacokinetics: Time to maximum plasma concentration		Approximately 1 month	No
Secondary	Pharmacokinetics: Renal clearance		Approximately 1 month	No
Secondary	Pharmacokinetics: Apparent volume of distribution		Approximately 1 month	No
Secondary	Pharmacokinetics: Apparent clearance		Approximately 1 month	No
Secondary	Pharmacokinetics: Amount excreted in the urine		Approximately 1 month	No
Secondary	Pharmacokinetics: Fraction of drug excreted in urine		Approximately 1 month	No
Secondary	Safety: Incidence of adverse events		Approximately 2 months	No