A Study of Selexipag in Healthy Male Participant

Healthy Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266756
• Other study ID #: CR108709
• Secondary ID: 2019-004150-2967
• Status: Completed
• Phase: Phase 1
• Start date: January 23, 2020
• Est. completion date: August 14, 2020

Study information

• Verified date: September 2020
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 14, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Selexipag matrix tablet
Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.
• Selexipag encapsulated pellets
Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.
• Selexipag Immediate-release (IR) tablet
Participants will receive Selexipag immediate-release tablet orally under fasted condition.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Up to 50 Days