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

NCT02882425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

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.

DRUG

Selexipag for oral use

Tablet containing 200 µg of selexipag

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Priska Kaufmann, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02882425 on ClinicalTrials.gov