Clinical trial NCT05427162: A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist
Official title: Open-Label, Randomized Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Different Formulations of an IP Receptor Agonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2022-06-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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
* 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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 114 days
measure: Number of Participants With Serious TEAEs
timeFrame: Up to 114 days
measure: Number of Participants with TEAEs by Severity
timeFrame: Up to 114 days
measure: Number of Participants with TEAEs Leading to Discontinuation
timeFrame: Up to 114 days
measure: Number of Participants With Change from Baseline in Clinical Laboratory Values
timeFrame: Up to 114 days
measure: Number of Participants With Injection Site Reactions
timeFrame: Up to 114 days
Secondary outcomes:
measure: Treatment Period 1: Maximum Observed Plasma Concentration of Prostacyclin Receptor Agonist at Steady State (Cmax[ss])
timeFrame: Up to 114 days
measure: Treatment Period 1: Time to Reach Maximum Observed Plasma Concentration of Prostacyclin Receptor Agonist at Steady State (Tmax[ss])
timeFrame: Up to 114 days
measure: Treatment Period 1: Area Under the Curve From Time Zero to tau of Prostacyclin Receptor Agonist at Steady State (AUC[0-tau{ss}])
timeFrame: Up to 114 days
measure: Treatment Period 1: Plasma Concentration at the End of One Dose Interval of Prostacyclin Receptor Agonist at Steady State (Ctrough[ss])
timeFrame: Up to 114 days
measure: Treatment Period 2: Maximum Observed Plasma Concentration (Cmax) of Prostacyclin Receptor Agonist
timeFrame: Up to 114 days
measure: Treatment Period 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prostacyclin Receptor Agonist
timeFrame: Up to 114 days
measure: Treatment Period 2: Area Under the Plasma Concentration-time Curve from time Zero to time t (AUC[0-t]) of Prostacyclin Receptor Agonist
timeFrame: Up to 114 days
measure: Treatment Period 2: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Prostacyclin Receptor Agonist
timeFrame: Up to 114 days
measure: Treatment Period 2: Area Under the Plasma Concentration-time Curve From Zero to Time 24 Hours (AUC [0-24h]) of Prostacyclin Receptor Agonist
timeFrame: Predose up to 24 hours post dose
measure: Treatment Period 2: Area Under the Plasma Concentration-time Curve From Zero to Day 14 (AUC [0-Day 14]) of Prostacyclin Receptor Agonist
timeFrame: Up to Day 14
measure: Treatment Period 2: Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC [0-Day 28]) of Prostacyclin Receptor Agonist
timeFrame: Up to Day 28
measure: Treatment Period 2: Plasma Concentration of Prostacyclin Receptor Agonist at Day 14 (C[Day 14])
timeFrame: Up to Day 14
measure: Treatment Period 2: Plasma Concentration of Prostacyclin Receptor Agonist at Day 28 (C[Day 28])
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Actelion
name: Actelion Pharmaceuticals Ltd. Clinical Trials
role: STUDY_DIRECTOR
References: