A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Study Purpose
The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Inclusion Criteria:
- - Participants must be ≥ 18 to ≤ 75 years at the time of signing the informed consent form (ICF).
- - Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) [pulmonary arterial hypertension (PAH)] in any of the following subtypes: 1.
- - PAH diagnosis for at least 3 months.
- - Participants must be on stable PH therapy consisting of up to 2 medications from the following classes: 1.
- - No change in PH medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 30 days prior to Screening.
- - No change in long-term diuretic use or dosage for at least 30 days prior to Screening.
- - Body Mass Index (BMI) within the range 18.0-37.0 kg/m^2 (inclusive).
- - Male participants: Male participants who are not sterile and have female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
- - Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie, post-tubal ligation for at least 12 months) or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.
- - Male participants with pregnant or non-pregnant woman of childbearing potential partner must use a condom in order to avoid potential exposure to embryo/fetus.
- - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion Criteria:
- - History of PH other than idiopathic, hereditary, drug/toxin-induced, repaired simple congenital heart disease, or CTD-associated PAH (eg, complex, congenital heart disease-associated PAH, portal hypertension-associated PAH, PH belonging to Groups 2 through 5).
- - Allergy, or documented hypersensitivity or contraindication, to TPIP or Treprostinil or mannitol (an excipient of the TPIP formulation).
- - Any known ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any symptomatic bradycardia.
- - History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
- - Participation in a cardio-pulmonary rehabilitation program within 1 month of Screening Visit.
- - Evidence of thromboembolic disease as assessed by ventilation-perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
- - Active liver disease or hepatic dysfunction.
- - History of HIV infection.
- - Established diagnosis of hepatitis B viral infection, or positive for hepatitis B surface antigen (HBsAg) at the time of Screening.
- - Established diagnosis of hepatitis C viral infection at the time of screening.
- - Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
- - Use of live attenuated vaccines within 30 days of the Screening Visit.
- - Participants with Down's Syndrome.
- - History of abnormal bleeding or bruising.
- - History of solid organ transplantation.
- - Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune compromised status, as judged by the Investigator.
- - History of alcohol or drug abuse within 6 months prior to Screening.
- - Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
- - Participants with current or recent (past 30 days) lower respiratory tract infection.
- - History of malignancy in the past 5 years, with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
- - Change in PH medication (endothelin receptor agonists, phosphoesterase type 5 inhibitors, and guanylate cyclase stimulators or diuretics) between Screening and Baseline.
- - Have participated in any other interventional clinical studies within 30 days prior to Screening.
- - Current use of cigarettes (as defined by Centers for Disease Control and Prevention) or e-cigarettes.
- - Participants who currently inhale marijuana (recreational or medical).
- - Pregnant or breastfeeding.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05147805 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Insmed Incorporated |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Austria, Belgium, Brazil, Denmark, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Arterial Hypertension |
Arms
Experimental: Treprostinil Palmitil Inhalation Powder
Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be up-titrated to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.
Placebo Comparator: Placebo
Participants will be administered a placebo matching TPIP once per day for 16 weeks.
Interventions
Drug: - Treprostinil Palmitil
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
Drug: - Placebo
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
USA022
Scottsdale, Arizona, 85258-4566
Status
Recruiting
Address
USA021
Tucson, Arizona, 85724-0001
Status
Recruiting
Address
USA002
West Hollywood, California, 90048-1804
Status
Recruiting
Address
USA008
Gainesville, Florida, 32610-3003
Status
Recruiting
Address
USA005
Jacksonville, Florida, 32224
Status
Recruiting
Address
USA007
Orlando, Florida, 32803-1248
Status
Recruiting
Address
USA011
Tampa, Florida, 33601-1289
Status
Recruiting
Address
USA009
Atlanta, Georgia, 30309-1281
Status
Recruiting
Address
USA006
Chicago, Illinois, 60611-5980
Status
Recruiting
Address
USA001
Chicago, Illinois, 60612-7323
Status
Recruiting
Address
USA013
Indianapolis, Indiana, 46260-1992
Status
Recruiting
Address
USA014
Iowa City, Iowa, 52242-1009
Status
Recruiting
Address
USA003
Kansas City, Kansas, 66160
Status
Recruiting
Address
USA102
New York, New York, 10021-9800
Status
Recruiting
Address
USA017
New York, New York, 10032-1559
Status
Recruiting
Address
USA016
Dallas, Texas, 75246-2073
Status
Recruiting
Address
USA012
Denison, Texas, 75020
Status
Recruiting
Address
USA018
Houston, Texas, 77030-1501
International Sites
Status
Recruiting
Address
ARG009
Quilmes, Buenos Aires, B1878GEG
Status
Recruiting
Address
ARG002
Rosario, Santa Fe, S2013DSR
Status
Recruiting
Address
ARG006
Rosario, Santa Fe, S2013KDS
Status
Recruiting
Address
ARG007
San Miguel de Tucuman, Tucumán, T4000AXL
Status
Recruiting
Address
ARG008
Cuiudad Autónoma De Buenos Aires, , C1430EGF
Status
Recruiting
Address
ARG001
Córdoba, , X5000FPQ
Status
Recruiting
Address
AUS005
New Lambton Heights, New South Wales, 2305
Status
Recruiting
Address
AUS004
Milton, Queensland, 4064
Status
Recruiting
Address
AUS001
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
AUS003
Adelaide, South Australia, 5000
Status
Recruiting
Address
AUS002
Hobart, Tasmania, 7000
Status
Recruiting
Address
AUT002
Linz, Oberösterreich, 4020
Status
Recruiting
Address
AUT001
Wien, , 1090
Status
Recruiting
Address
BEL003
Anderlecht, Brussels, 1070
Status
Recruiting
Address
BEL002
Leuven, Vlaams Brabant, 3000
Status
Recruiting
Address
BEL001
Liège, , 4000
Status
Recruiting
Address
BRA003
Belo Horizonte, Minas Gerais, 30130
Status
Recruiting
Address
BRA004
Belo Horizonte, Minas Gerais, 30441-070
Status
Recruiting
Address
BRA007
Passo Fundo, Rio Grande Do Sul, 99010-120
Status
Recruiting
Address
BRA006
Porto Alegre, Rio Grande Do Sul, 90035-003
Status
Recruiting
Address
BRA002
Blumenau, Santa Catarina, 80440-080
Status
Recruiting
Address
BRA001
São Paulo, , 05403-000
Status
Recruiting
Address
DNK001
Aarhus N, Central Jutland, 8200
Status
Recruiting
Address
GER005
Heidelberg, Baden-Württemberg, 69126
Status
Recruiting
Address
GER006
Dresden, Sachsen, 01307
Status
Recruiting
Address
GER002
Lübeck, Schleswig-Holstein, 23562
Status
Recruiting
Address
GER007
Berlin, , 12683
Status
Not yet recruiting
Address
GER003
Munich, , 80639
Status
Recruiting
Address
ITA003
Napoli, Campania, 80131
Status
Recruiting
Address
ITA006
Milano, Lombardia, 20123
Status
Recruiting
Address
ITA005
Monza, Lombardia, 20900
Status
Recruiting
Address
ITA002
Pavia, Lombardia, 27100
Status
Recruiting
Address
ITA001
Palermo, Sicilia, 90127
Status
Recruiting
Address
ITA004
Roma, , 00161
Status
Recruiting
Address
JPN005
Sapporo-Shi, Hokkaidô, 060-8543
Status
Recruiting
Address
JPN004
Sapporo-Shi, Hokkaidô, 060-8648
Status
Recruiting
Address
JPN007
Kurume-Shi, Hukuoka, 830-0011
Status
Recruiting
Address
JPN006
Tsukuba-Shi, Ibaraki, 305-8576
Status
Recruiting
Address
JPN001
Kagoshima-Shi, Kagosima, 890-8520
Status
Recruiting
Address
JPN009
Nagasaki-Shi, Nagasaki, 852-8501
Status
Recruiting
Address
JPN002
Okayama-Shi, Okayama, 701-1154
Status
Recruiting
Address
JPN008
Shinjuku-Ku, Tokyo, 160-8582
Status
Recruiting
Address
JPN003
Suita-Shi, Ôsaka, 564-8565
Status
Recruiting
Address
MYS005
Kota Setar, Kedah, 05460
Status
Recruiting
Address
MYS002
Kuantan, Pahang, 25200
Status
Recruiting
Address
MYS003
Kajang, Selangor, 43000
Status
Recruiting
Address
MYS004
Sungai Buloh, Selangor, 47000
Status
Recruiting
Address
MEX005
Lomas De Guevara, Jalisco, 44657
Status
Recruiting
Address
MEX003
Mexico, , 14080
Status
Recruiting
Address
MEX004
San Luis Potosí, , 78200
Status
Recruiting
Address
MEX001
Sertoma, , 64718
Status
Recruiting
Address
PHL001
Quezon City, National Capital Region, 1100
Status
Recruiting
Address
PHL002
Makati City, , 1229
Status
Recruiting
Address
SRB004
Beograd, Belgrade, 116550
Status
Recruiting
Address
SRB001
Belgrade, , 11000
Status
Recruiting
Address
SRB003
Belgrade, , 11000
Status
Not yet recruiting
Address
ESP009
Oviedo, Asturias, 33011
Status
Recruiting
Address
ESP006
Palma de Mallorca, Baleares, 07010
Status
Recruiting
Address
ESP001
Santander, Cantabria, 39008
Status
Recruiting
Address
ESP002
Barcelona, , 8025
Status
Recruiting
Address
ESP007
Las Palmas, , 35010
Status
Recruiting
Address
ESP008
Madrid, , 28046
Status
Recruiting
Address
ESP003
Sevilla, , 41009
Status
Recruiting
Address
ESP004
Toledo, , 45007
Status
Recruiting
Address
CHE002
Lausanne, Vaud (fr), CH-1011
Status
Recruiting
Address
GBR001
Bath, Avon, BA1 3NG
Status
Recruiting
Address
GBR002
Glasgow, Lanarkshire, G81 4HX
Status
Recruiting
Address
GBR006
London, London, City Of, W12 0HS
Status
Recruiting
Address
GBR003
Newcastle Upon Tyne, Tyne And Wear, NE3 3HD
Status
Recruiting
Address
GBR004
London, , NW3 2Q