Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.

NCT02238782

Healthy Volunteers Bioavailability Study

COMPLETED PHASE1

A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions

NCT03438461

Healthy

COMPLETED PHASE1

A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants

NCT03682380

Healthy

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers

NCT02322749

Healthy Volunteers Bioequivalence or Bioavailability Study

COMPLETED PHASE1

AZD9056 Relative Bioavailability Study

NCT00908934

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A pilot phase was conducted in 3 male subjects before the main phase for assessment of absolute bio-availability conducted in 16 other male subjects. The pilot phase aimed to determine the intravenous dose to be used in the main phase based on safety data and pharmacokinetics data.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous selexipag (Pilot phase)

Subjects received a 20-minute intravenous (i.v.) infusion of 50 µg selexipag

Group Type EXPERIMENTAL

Selexipag for intravenous use

Intervention Type DRUG

Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.

Sequence A-B (Main phase)

Subjects received a 80-minute i.v. infusion of 200 µg selexipag during Period 1, and 2 tablets of oral selexipag (total dose of 400 µg) as a single administration during Period 2. A washout period of 7 to 10 days separated the i.v. infusion from the oral administration.

Group Type EXPERIMENTAL

Selexipag for intravenous use

Intervention Type DRUG

Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.

Selexipag for oral use

Intervention Type DRUG

Tablet containing 200 µg of selexipag

Sequence B-A (Main phase)

Subjects received 2 tablets of oral selexipag (total dose of 400 µg) as a single administration during Period 1, and a 80-minute i.v. infusion of 200 µg selexipag during Period 2. A washout period of 7 to 10 days separated the oral administration from the i.v. infusion.

Group Type EXPERIMENTAL

Selexipag for intravenous use

Intervention Type DRUG

Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.

Selexipag for oral use

Intervention Type DRUG

Tablet containing 200 µg of selexipag

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Selexipag for intravenous use

Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.

Intervention Type DRUG

Selexipag for oral use

Tablet containing 200 µg of selexipag

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACT-293987 ACT-293987

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed informed consent prior to any study-mandated procedure
* Aged from 18 to 45 (inclusive) at screening
* Body mass index (BMI) from 18.0 to 28.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

Exclusion Criteria

* Any contraindication to the study drug formulations
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes