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

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ClinicalTrials.gov Identifier: NCT01701739
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: aleglitazar Drug: digoxin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arms and Interventions
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Arm Intervention/treatment
Experimental: aleglitazar / digoxin Drug: aleglitazar
Multiple doses of aleglitazar

Drug: digoxin
Single dose of digoxin


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration time curve [ Time Frame: Approximately 1 month ]
  2. Pharmacokinetics: maximum plasma concentration [ Time Frame: Approximately 1 month ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Elimination half-life [ Time Frame: Approximately 1 month ]
  2. Pharmacokinetics: Time to maximum plasma concentration [ Time Frame: Approximately 1 month ]
  3. Pharmacokinetics: Renal clearance [ Time Frame: Approximately 1 month ]
  4. Pharmacokinetics: Apparent volume of distribution [ Time Frame: Approximately 1 month ]
  5. Pharmacokinetics: Apparent clearance [ Time Frame: Approximately 1 month ]
  6. Pharmacokinetics: Amount excreted in the urine [ Time Frame: Approximately 1 month ]
  7. Pharmacokinetics: Fraction of drug excreted in urine [ Time Frame: Approximately 1 month ]
  8. Safety: Incidence of adverse events [ Time Frame: Approximately 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701739


Locations
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United Kingdom
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01701739    
Other Study ID Numbers: BP25562
2012-002269-36 ( EudraCT Number )
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs