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

NCT01701739 | Completed Phase 1

• 2 other identifiers: BP255622012-002269-36
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area under the concentration time curve

  Approximately 1 month

• Pharmacokinetics: maximum plasma concentration

  Approximately 1 month

Secondary Outcomes (8)

• Pharmacokinetics: Elimination half-life

  Approximately 1 month

• Pharmacokinetics: Time to maximum plasma concentration

  Approximately 1 month

• Pharmacokinetics: Renal clearance

  Approximately 1 month

• Pharmacokinetics: Apparent volume of distribution

  Approximately 1 month

• Pharmacokinetics: Apparent clearance

  Approximately 1 month

Study Arms (1)

aleglitazar / digoxin

EXPERIMENTAL

Drug: aleglitazar; Drug: digoxin

Interventions

aleglitazar DRUG

Multiple doses of aleglitazar

aleglitazar / digoxin

digoxin DRUG

Single dose of digoxin

aleglitazar / digoxin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

aleglitazar; Digoxin

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)