Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8 film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a multiple-dose up-titration scheme.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Actelion
• Treatments: Selexipag

Criteria

Inclusion Criteria:

• Signed informed consent in the local language prior to any study-mandated procedure.

• Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.

• No clinically significant findings on the physical examination at Screening.

• Body mass index of 18.0 to 30.0 kg/m^2 (inclusive) at Screening.

• Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (all inclusive), measured at Screening.

• 12-lead electrocardiogram without clinically relevant abnormalities, measured at Screening.

• Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at Screening.

• Negative results from urine drug screen and alcohol breath test at Screening.

• Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

• Known allergic reactions or hypersensitivity to selexipag or any excipient of the drug formulation used in this study.

• 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 selexipag.

• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.

• Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).

• Treatment with selexipag or another investigational drug within 1 month prior to Screening or 5 half-lives, whichever is longer.

• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.

• Excessive caffeine consumption at Screening.

• Smoking within 3 months prior to Screening and inability to refrain from smoking during the course of the study.

• Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications within 2 weeks prior to first study drug administration.

• Loss of 500 mL or more of blood within 3 months prior to Screening.

• Positive results from the hepatitis serology (hepatitis B antigen and hepatitis C antibodies), except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.

• Positive results from the human immunodeficiency virus serology at Screening.

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

• Legal incapacity or limited legal capacity at Screening.