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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: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


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:

Drug Information available for: Digoxin
U.S. FDA Resources

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
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: May 23, 2013
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 May 23, 2013