Status:
COMPLETED
Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
Lead Sponsor:
Actelion
Conditions:
Cardiodynamics
Safety
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxiflo...
Eligibility Criteria
Inclusion
- Signed, dated written informed consent prior to any study procedure.
- Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study.
- Women of childbearing potential must have had a negative serum pregnancy test at screening and a negative serum pregnancy test on Day -1. Women of childbearing potential must have consistently and correctly used a reliable method of contraception with a failure rate of \< 1% per year, been sexually inactive, or have vasectomized partner.
- Healthy based on medical history and assessments performed at screening and on Day -1.
- Body mass index ≥ 18.5 and ≤ 32 kg/m\^2 at screening. Body weight at least 50 kg.
- Negative results from urine drug screen at screening and on Day -1 and negative urine alcohol test on Day -1.
- Willing to refrain from alcohol consumption from at least 48 hours prior to clinic admission to the end of study.
- Systolic blood pressure 90-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute, at screening and Day -1.
- Hematology, blood chemistry, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening and Day -1.
Exclusion
- Known hypersensitivity to selexipag, moxifloxacin, or excipients of the drug formulations used in this study.
- Treatment with selexipag or an investigational drug prior to screening within 30 days or 6 half-lives, whichever was longer.
- History or clinical evidence of any disease and/or the existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of selexipag and moxifloxacin.
- Caffeine consumption of equal to or greater than 800 mg per day at screening.
- History of fainting, collapse, syncope, blackouts, orthostatic hypotension, or vasovagal reactions.
- Chronic or relevant acute infections.
- History of relevant allergy / hypersensitivity.
- History of clinical evidence of psychiatric disease, alcoholism, or drug abuse within the 3-year period prior to screening.
- Smoking within the 3 months prior to screening and inability to refrain from smoking during the study.
- Loss of 500 mL or more of blood within 56 days prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects at screening.
- Positive results from human immunodeficiency virus serology at screening.
- Previous treatment with any prescribed or over-the-counter medications, with the exception of contraceptives and hormone replacement therapy, within the 2 weeks prior to first study drug administration or 5 half-lives, whichever longer.
- Excessive physical activities within 1 week prior to administration of study drug.
- Any cardiac condition (including ECG abnormalities) or illness with a potential to increase the cardiac risk of the subject or that may affect QTc analysis.
- QTc \> 450 ms or \> 470 ms for male or female subjects, respectively, at screening and Day -1.
- Clinically relevant abnormalities on ECG, at screening and Day -1.
- Personal or family history of long QT syndrome or hypokalemia.
- Legal incapacity or limited legal capacity.
- Veins unsuitable for intravenous puncture on either arm.
- Any circumstances or conditions, which, in the opinion of the investigator, may affected the subject's participation in the study or compliance with the protocol.
- Pregnant or nursing women.
- Women who plan to become pregnant within 1 month of the end of study.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT02206204
Start Date
June 1 2012
End Date
November 1 2012
Last Update
August 1 2014
Active Locations (1)
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1
Covance Clinical Research Unit
Evansville, Indiana, United States, 47710