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Trial record 32 of 1053 for:    clopidogrel

A Clinical Study to Assess the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT03496506
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
The purpose of this study is to evaluate the effect of clopidogrel on the pharmacokinetics of selexipag and its active metabolite (ACT-333679) in healthy male adults (by determining the blood concentrations of selexipag and its metabolite). Also, the safety of selexipag when administered alone or with clopidogrel will be assessed.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Selexipag Drug: Clopidogrel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, two-treatment, one-sequence, cross-over study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Open-label, Two-treatment, One-sequence, Cross-over Study to Investigate the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite, ACT-333679, in Healthy Male Subjects
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : May 18, 2018

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Arm Intervention/treatment
Experimental: Sequential treatment arm
Subjects receive 1 tablet of selexipag twice daily from Day 1 to Day 9 and 1 tablet in the morning of Day 10. In the morning of Day 4 and 1 hour before the administration of selexipag, they receive 4 tablets of clopidogrel. Then from Day 5 to Day 10, 1 hour before the morning administration of selexipag, they receive 1 tablet of clopidogrel .
Drug: Selexipag
Each film-coated tablet contains 200 microgram (mcg) of selexipag (oral use)
Other Name: ACT-293987

Drug: Clopidogrel
Each film-coated tablet containing 75 mg of clopidogrel (oral use)




Primary Outcome Measures :
  1. Area under the plasma concentration-time profile of selexipag and ACT-333679 during a dose interval (AUC-tau) [ Time Frame: Blood samples at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dose on Day 3, Day 4 and Day 10 ]
    AUC-tau for selexipag and ACT-333679 is calculated on the basis of the actual blood sampling time points drawn during the 12-hour interval after the morning administration of selexipag administered either alone (Day 3) or concomitantly with clopidogrel (Day 4 and Day 10)

  2. Maximal plasma concentration of selexipag and ACT-333679 (Cmax) [ Time Frame: Blood samples at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dose on Day 3, Day 4 and Day 10 ]
    Cmax is directly derived from the individual plasma concentration-time curves for selexipag and ACT-333679, following administration of selexipag alone (Day 3) or concomitantly with clopidogrel (Day 4 and Day 10)


Secondary Outcome Measures :
  1. Trough plasma concentration of selexipag and ACT-333679 (Ctrough) [ Time Frame: Blood samples from Day 1 to Day 9 before the morning and evening administrations of selexipag and on Day 10 before the morning administration of selexipag ]
    Ctrough is the concentration of selexipag and ACT-333679 directly measured in the blood samples collected prior to the morning and evening administrations of selexipag

  2. Time to reach Cmax (tmax) [ Time Frame: Blood samples at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post-dose on Day 3, Day 4 and Day 10 ]
    tmax is the time to reach the maximal plasma concentration of selexipag and ACT-333679 and it is directly derived from the individual plasma concentration-time curves for selexipag and ACT-333679, following administration of selexipag alone (Day 3) or concomitantly with clopidogrel (Day 4 and Day 10)

  3. Number of participants with any treatment-emergent adverse events (TEAEs) including serious adverse events [ Time Frame: From the first selexipag administration on Day 1 up to Day 18 (about 1 week after the last administration of selexipag) ]
    A treatment-emergent adverse event is any adverse event temporally associated with the use of a study treatment, whether or not considered related to the study treatment



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent in the local language prior to any study-mandated procedure.
  • Healty male subjects aged between 18 and 45 years (inclusive) at screening.
  • Body mass index from 18.0 to 28.0 kg/m2 (inclusive) at screening.
  • Systolic blood pressure (SBP) 100−145 mmHg, diastolic blood pressure (DBP) 50−90 mmHg, and pulse rate 45−90 bpm (inclusive).

Exclusion Criteria:

  • Any contraindication included in the SmPC of selexipag or clopidogrel treatment.
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments.
  • History or clinical evidence of any disorder of hemostasis, hemorrhagic diathesis, nose or gingival bleeding, hemophilia, thrombotic thrombocytopenic purpura, presence of any lesions with a propensity to bleed (particularly gastrointestinal and intraocular), history of bleeding complications after surgical procedures such as tooth extraction
  • Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension,vasovagal reactions, head injury.
  • Excessive caffeine consumption
  • Nicotine consumption within 3 months prior to screening, and inability to refrain from nicotine consumption during the course of the study
  • Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first selexipag administration.
  • Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Information from the National Library of Medicine

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): NCT03496506


Locations
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Belgium
Clinical Pharmacology Unit (CPU)
Merksem, Belgium, 2170
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Shirin Bruderer Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03496506     History of Changes
Other Study ID Numbers: AC-065-117
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Actelion:
selexipag
clopidogrel
Additional relevant MeSH terms:
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Clopidogrel
Selexipag
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents