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A Study of Selexipag in Healthy Male Participant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266756
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Selexipag matrix tablet Drug: Selexipag encapsulated pellets Drug: Selexipag Immediate-release (IR) tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : August 8, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Selexipag

Arm Intervention/treatment
Experimental: Cohort 1: Selexipag Matrix Tablets
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
Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.
Other Name: JNJ-67896049

Drug: Selexipag Immediate-release (IR) tablet
Participants will receive Selexipag immediate-release tablet orally under fasted condition.
Other Name: JNJ-67896049

Experimental: Cohort 2: Selexipag Encapsulated Pellets
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
Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.
Other Name: JNJ-67896049

Drug: Selexipag Immediate-release (IR) tablet
Participants will receive Selexipag immediate-release tablet orally under fasted condition.
Other Name: JNJ-67896049




Primary Outcome Measures :
  1. Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679 [ Time Frame: Predose and 0 to 72 hours postdose ]
    The Cmax is the maximum observed analyte concentration.

  2. Area Under Analyte Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) of Selexipag and ACT-333679 [ Time Frame: Predose and 0 to 72 hours postdose ]
    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.

  3. Plasma analyte concentration 24 hours (C24) Post Dose of Selexipag and ACT-333679 [ Time Frame: Predose and 0 to 72 hours postdose ]
    C24 defined as plasma analyte concentration at 24 hours postdose.

  4. Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) [ Time Frame: Predose and 0 to 72 hours postdose ]
    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.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 50 Days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

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): NCT04266756


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Belgium
Clinical Pharmacology Unit Recruiting
Merksem, Belgium, 2170
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Additional Information:
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT04266756    
Other Study ID Numbers: CR108709
2019-004150-29 ( EudraCT Number )
67896049PAH1001 ( Other Identifier: Actelion )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Selexipag
Antihypertensive Agents