A Study to Evaluate the Safety, Tolerability and Pharmaco... | NCT06091579

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A (SAD Cohort 1): TPIP	Experimental	Participants in the single ascending dose (SAD) Cohort 1 received a single dose of TPIP at Dose A, Dose B, or Dose C by oral inhalation on Day 1.	Drug: Treprostinil Palmitil Inhalation Powder
Part A (SAD Cohort 2): TPIP or Placebo	Experimental	Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1.	Drug: Treprostinil Palmitil Inhalation Powder Drug: Placebo
Part A (SAD Cohort 3): TPIP or Placebo	Experimental	Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1.	Drug: Treprostinil Palmitil Inhalation Powder Drug: Placebo
Part B (MAD Cohort 1): TPIP or Placebo	Experimental	Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7.	Drug: Treprostinil Palmitil Inhalation Powder Drug: Placebo
Part B (MAD Cohort 2): TPIP or Placebo	Experimental	Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treprostinil Palmitil Inhalation Powder	Drug	Oral inhalation using a Plastiape capsule-based dry powder inhaler.	Part A (SAD Cohort 1): TPIP Part A (SAD Cohort 2): TPIP or Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parts A and B: Number of Participants who Experienced an Adverse Event (AE)	Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.	Up to Day 31 in Part A and Day 37 in Part B

Secondary Outcomes

Measure	Description	Time Frame
Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil	Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants.	Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant is considered by the investigator to be in good general health as determined by medical history, physical examination findings, vital sign measurements, 12-lead electrocardiogram (ECG) results, and clinical laboratory test results within normal limits or considered not clinically significant by the investigator, at screening.

Exclusion Criteria:

The participant has an allergy, documented hypersensitivity, or contraindication to the ingredients or to any of the excipients of treprostinil palmitil inhalation powder or treprostinil.
The participant has used any prescription (excluding hormonal birth control) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before the first dose of study drug and throughout the study.
The participant has a history of anaphylaxis, previously documented hypersensitivity reaction to any drug.
The participant has had a surgical procedure that required general anesthesia (or equivalent) within 90 days prior to screening.
The participant has a body mass index <19.0 or >32.0 kilograms per square meter (kg/m^2) at screening.
The participant has a history of syncope not due to dehydration or vasovagal syncope (eg, congenital cardiac arrhythmias such as Wolff-Parkinson-White syndrome, nodal tachycardia, ventricular tachycardia, etc).
The participant has active liver disease or hepatic dysfunction at screening or check-in visits.
The participant has a history of human immunodeficiency virus (HIV) infection.
The participant has a history of abnormal bleeding or bruising.
The participant has a history of malignancy in the past 5 years, with exception of nonmelanoma skin cancer.
The participant has a current history (within the past 12 months) of substance and/or alcohol abuse.
The participant is a current user of cigarettes (average of ≥1 cigarette/day) or e-cigarettes within 30 days prior to screening.
The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug or throughout the study.

Note: Other inclusion/exclusion criteria may apply.

Facility	Status	City	State	ZIP	Country	Contacts
USA001		Austin	Texas	78744	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36070132	Result	Ismat FA, Usansky HH, Villa R, Zou J, Teper A. Safety, Tolerability, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder for Pulmonary Hypertension: A Phase 1, Randomized, Double-Blind, Single- and Multiple-Dose Study. Adv Ther. 2022 Nov;39(11):5144-5157. doi: 10.1007/s12325-022-02296-x. Epub 2022 Sep 7.