A Study of Selexipag in Healthy Male Participant | NCT04266756

NCT04266756

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2019-004150-29	EudraCT Number
67896049PAH1001	Other Identifier	Actelion

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Selexipag Matrix Tablets	Experimental	Participants will receive oral doses of selexipag matrix tablets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period.	Drug: Selexipag matrix tablet Drug: Selexipag Immediate-release (IR) tablet
Cohort 2: Selexipag Encapsulated Pellets	Experimental	Participants will receive oral doses of selexipag encapsulated) pellets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period.	Drug: Selexipag encapsulated pellets Drug: Selexipag Immediate-release (IR) tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selexipag matrix tablet	Drug	Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.	Cohort 1: Selexipag Matrix Tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679	The Cmax is the maximum observed analyte concentration.	Predose and 0 to 72 hours postdose
Area Under Analyte Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) of Selexipag and ACT-333679	AUC (0-last) defined as the area under the analyte concentration-time curve from time zero to time of the last measurable (non-BQL) analyte concentration, calculated by linear-linear trapezoidal summation.	Predose and 0 to 72 hours postdose
Plasma analyte concentration 24 hours (C24) Post Dose of Selexipag and ACT-333679	C24 defined as plasma analyte concentration at 24 hours postdose.	Predose and 0 to 72 hours postdose
Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])	AUC (0-infinity) is defined the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.	Predose and 0 to 72 hours postdose

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participants may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
Body mass index (BMI; weight (kilogram [kg]/height^2 [meter {m}]^2) between 18.0 and 28.0 kilogram per square centimeter (kg/m^2) (inclusive), and body weight not less than 50.0 kg at screening
Blood pressure (after the participant is supine for 5 minutes) between 90 and 145 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening. If blood pressure is out of range, up to 2 repeated assessments within the screening period are permitted, last assessment being conclusive

Exclusion Criteria:

Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening and on Day -1 of Treatment Period 1 as deemed appropriate by the investigator
Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
Any contraindication included in the Summary of Product Characteristics (SmPC) of selexipag
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 (appendectomy and herniotomy allowed, cholecystectomy not allowed)
Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension, vasovagal reactions, head injury

Name	Affiliation	Role
Janssen-Cilag International NV Clinical Trial	Janssen-Cilag International NV	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Pharmacology Unit		Merksem		2170	Belgium

IPD Sharing Statement Module

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations