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

Actelion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Prostacyclin Receptor Agonist

Study type: Interventional

Funder types: Industry

Identifiers

NCT05427162

CR109201

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Prostacyclin Receptor Agonist

Experimental group

Description:

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:

Drug: Prostacyclin Receptor Agonist