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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01701739
First received: October 3, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label, two-period, fixed-sequence study will investigate the pharmacok inetics 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 dig oxin, in period 2 volunteers will receive multiple doses of aleglitazar and a si ngle dose of digoxin. The anticipated time on study treatment is one month.


Condition Intervention Phase
Healthy Volunteer
Drug: aleglitazar
Drug: digoxin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the concentration time curve [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum plasma concentration [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Elimination half-life [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time to maximum plasma concentration [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Renal clearance [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Apparent volume of distribution [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Apparent clearance [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Amount excreted in the urine [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Fraction of drug excreted in urine [ Time Frame: Approximately 1 month ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aleglitazar / digoxin Drug: aleglitazar
Multiple doses of aleglitazar
Drug: digoxin
Single dose of digoxin

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701739

Locations
United Kingdom
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01701739     History of Changes
Other Study ID Numbers: BP25562, 2012-002269-36
Study First Received: October 3, 2012
Last Updated: July 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014