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Prostacyclin Receptor Agonist

Prostacyclin Agonist for Pulmonary Arterial Hypertension

Phase 1
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 114 days
Awards & highlights

Study Summary

This trial is testing a new medication for safety and how well it works.

Who is the study for?
This trial is for adults with a BMI of 18.0-32.0 kg/m^2 and weight over 50kg, without significant health issues based on physical exams, ECGs, and lab tests. Women must not be pregnant; men agree to not donate sperm during the study and for 90 days after. Excluded are those with allergies to prostacyclin or similar drugs, abnormal ECGs, HIV/HBsAg/HCV/COVID-19 positive tests, recent cancer (except certain skin cancers), or frequent fainting due to heart problems.Check my eligibility
What is being tested?
The study is testing the safety and tolerability of different formulations of a prostacyclin receptor agonist in two treatment periods among patients with Pulmonary Arterial Hypertension.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from prostacyclin receptor agonists include headache, diarrhea, jaw pain, nausea/vomiting; more serious risks involve bleeding complications or cardiovascular effects like chest pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to donate sperm during and for 3 months after the study.
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My BMI is between 18.0 and 32.0, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 114 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 114 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Change from Baseline in Clinical Laboratory Values
Number of Participants With Injection Site Reactions
Number of Participants With Serious TEAEs
+3 more
Secondary outcome measures
Treatment Period 1: Area Under the Curve From Time Zero to tau of Prostacyclin Receptor Agonist at Steady State (AUC[0-tau{ss}])
Treatment Period 1: Maximum Observed Plasma Concentration of Prostacyclin Receptor Agonist at Steady State (Cmax[ss])
Treatment Period 1: Plasma Concentration at the End of One Dose Interval of Prostacyclin Receptor Agonist at Steady State (Ctrough[ss])
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prostacyclin Receptor AgonistExperimental Treatment1 Intervention
Participants in Cohort 1-7 will receive multiple doses of prostacyclin receptor agonist of formulation 1 in treatment period 1, followed by a single dose of various other formulations (formulation 2, 3, and 4) in treatment period 2. Cohort 7 will be optional. Doses in Cohorts 4, 5, 6 and cohort 7 will be based on PK, safety and tolerability data of previous 3 cohorts (preceding cohorts).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prostacyclin Receptor Agonist
2022
Completed Phase 1
~90

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,605 Total Patients Enrolled
66 Trials studying Pulmonary Arterial Hypertension
15,897 Patients Enrolled for Pulmonary Arterial Hypertension
Actelion Pharmaceuticals Ltd. Clinical TrialsStudy DirectorActelion

Media Library

Prostacyclin Receptor Agonist (Prostacyclin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05427162 — Phase 1
Pulmonary Arterial Hypertension Research Study Groups: Prostacyclin Receptor Agonist
Pulmonary Arterial Hypertension Clinical Trial 2023: Prostacyclin Receptor Agonist Highlights & Side Effects. Trial Name: NCT05427162 — Phase 1
Prostacyclin Receptor Agonist (Prostacyclin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05427162 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this research endeavor attempting to achieve?

"According to the clinical study sponsor, Actelion, the primary metric of evaluation will be ‘Number of Participants with Treatment-emergent Adverse Events (TEAEs)’. This goal is going to be monitored over a maximum duration of 114 days. Alongside this main outcome measure, secondary endpoints include measurements such as 'AUC[0-Day 28]', which stands for Area Under The Plasma Concentration Curve From Zero To Day 28; 'C[Day 14]' and 'C[Day 28], both referring to plasma concentrations at those respective points in time."

Answered by AI

Are there any open enrollment opportunities for this medical experiment?

"According to the clinicaltrials.gov site, this research is presently enrolling participants; it was initially announced in June of 2022 and recently updated on November 15th of that same year."

Answered by AI

What is the extent of participation in this research endeavor?

"Affirmative. The clinical trial's listing on clinicaltrials.gov indicates that recruitment is ongoing; it was initially posted in June 2021 and most recently updated in November 2022, seeking 86 participants from one location."

Answered by AI

Is the age criterion for this trial limited to individuals under 35 years of age?

"This experiment necessitates that enrollees are aged between 18 and 55. Separately, there exists 54 trials for minors and 662 studies available to those over the age of 65."

Answered by AI

Do I qualify to volunteer for this clinical trial?

"This trial is enrolling 86 individuals between the ages of 18 and 55 that have been diagnosed with pulmonary arterial hypertension. Notably, all candidates must meet certain qualifications prior to enrollment including being in a medically stable condition as verified by laboratory tests; having a body mass index (BMI) within the range of 18-32 kg/m^2 inclusive as well as weigh at least 50kgs, demonstrate general health through physical exam, medical history, vital signs and 12 lead ECG results; female participants must also provide negative beta -hCG serum test results while male subjects are required not to donate sperm for reproduction during or up to 90"

Answered by AI

What potential hazards might individuals experience when taking a Prostacyclin Receptor Agonist?

"Our team at Power has rated the safety of Prostacyclin Receptor Agonist a 1 due to limited clinical research backing its efficacy and safety. This is an early-stage trial, so more data collection is needed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist
2022. "A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05427162.
~31 spots leftby Apr 2025
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