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NCT05427162CompletedPhase 1

A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist

Open-Label, Randomized Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Different Formulations of an IP Receptor Agonist

Source: ClinicalTrials.gov · Last updated 30 Mar 2025

Brief summary (registry, in English)

The purpose of the study is to assess safety and tolerability of prostacyclin receptor agonist formulation in treatment period 1 and with different formulation of prostacyclin receptor agonist in treatment period 2.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
88 (actual)
First submitted
16 Jun 2022
Start date
21 Jun 2022
Primary completion date
5 Dec 2023
Lead sponsor
Actelion
NCT number
NCT05427162

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 88
  • From 21 Jun 2022 to the primary completion date, 5 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known allergies, hypersensitivity, anaphylaxis, or intolerance to prostacyclin receptor agonist or drugs of the same class, or any excipient (including poloxamer and polysorbate) of the drug formulation(s)
  • History of malignancy within 3 years before screening (exceptions are squamous and basal cell carcinomas of the skin
  • Positive serologic testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (hBsAg), hepatitis C virus (HCV), active coronavirus disease 2019 (COVID-19) infection
  • A history of repeated (more than once over the last 30 days) fainting due to cardiac cause, collapse, syncope, orthostatic hypotension, or vasovagal reactions

Lab values

  • Clinically significant abnormal physical examination, vital signs, or 12-lead ECG (QTc greater than or equal to \[\>=\]450 milliseconds \[msec\] for men and \>=460 msec for women. QT corrected according to Bazett's formula \[QTcB\]) as assessed by the Investigator at Screening or Day -1 of oral treatment period

Who the study is looking for

  • Otherwise, healthy as deemed by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECG) performed at Screening and Day -1 of oral treatment period
  • Otherwise, healthy medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter square (kg/m\^2) (inclusive) and body weight not less than 50 kilograms (kg) at screening
  • All female participants must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening
  • A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Celerion
Coordinator of this site? Confirm its status
TempeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.