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A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Study Purpose
The primary objective of this study is to evaluate the safety and tolerability of
treprostinil palmitil inhalation powder (TPIP) compared with placebo
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 - 80 Years
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the
informed consent form (ICF).
- Male and female participants must use contraceptives that are consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies.
- Male participants:
Male participants who are not sterile, with 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.
Male participants with women of child bearing potential (WOCBP) partner must use a condom
in order to avoid potential exposure to embryo/fetus.
- Female participants: Women must be postmenopausal (defined as no menses for 12 months
without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or
bilateral salpingo-oophorectomy) 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.
- Capable of giving signed informed consent that includes compliance with the requirements
and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
- Primary diagnosis of chronic obstructive pulmonary disease (COPD).
- Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil
(TRE) or mannitol (an excipient of the TPIP formulation).
- Received or currently treated with riociguat, endothelin receptor antagonists,
selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within
30 days prior to Screening.
- Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if
already receiving either medication, there is a dose change within 30 days of
Screening Visit.
- Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal
atrial fibrillation), and/or 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 cardiopulmonary rehabilitation program within 30 days of the first
Screening Visit.
Participation in the maintenance program of a cardiopulmonary
rehabilitation program is allowed.
- Acutely decompensated heart failure within 30 days of Screening Visit.
- Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous
diagnosis of moderate to severe disease, or hospitalization due to COVID-19.
- Supplemental oxygen requirement > 10L/min at rest at Screening.
- Exacerbation of underlying lung disease or active pulmonary or upper respiratory
infection within 30 days of the first dose of study drug (may be rescreened at
appropriate time).
- Current or recent (past 30 days) lower respiratory tract infection (may be rescreened
at appropriate time).
- Any form of congenital heart disease or congenital heart defect (repaired or
unrepaired) other than a patent foramen ovale.
- History of alcohol or drug abuse within 6 months prior to Screening.
- Current use of cigarettes (as defined by Center for Disease Control (CDC)) or
e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime
and who currently smokes either every day or some days.
- Participants who currently inhale marijuana (recreational or medical).
- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with
study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris,
claudication, musculoskeletal disorder, need for walking aids).
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.
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
Active, not recruiting
Countries
Argentina, Australia, Belgium, Germany, Italy, New Zealand, Puerto Rico, Spain, United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Arms & Interventions
Arms
Experimental: Treprostinil Palmitil
Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up 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 daily.
Interventions
Drug: - Treprostinil Palmitil
Oral inhalation using a capsule-based dry powder inhaler device.
Drug: - Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
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.
USA007, Los Angeles, California
Status
Address
USA007
Los Angeles, California, 90033-5313
USA008, Aurora, Colorado
Status
Address
USA008
Aurora, Colorado, 80045-2541
USA010, Altamonte Springs, Florida
Status
Address
USA010
Altamonte Springs, Florida, 32701-4817
USA017, Tampa, Florida
Status
Address
USA017
Tampa, Florida, 33606
USA002, Atlanta, Georgia
Status
Address
USA002
Atlanta, Georgia, 30309-1281
USA013, Indianapolis, Indiana
Status
Address
USA013
Indianapolis, Indiana, 46260-1992
USA003, Kansas City, Kansas
Status
Address
USA003
Kansas City, Kansas, 66160-8500
USA015, Boston, Massachusetts
Status
Address
USA015
Boston, Massachusetts, 02111-1552
USA006, Springfield, Massachusetts
Status
Address
USA006
Springfield, Massachusetts, 01101
USA001, Houston, Texas
Status
Address
USA001
Houston, Texas, 77070
USA004, McKinney, Texas
Status
Address
USA004
McKinney, Texas, 75069-8085
International Sites
ARG006, Villa Vatteone, Buenos Aires, Argentina
Status
Address
ARG006
Villa Vatteone, Buenos Aires, B1853AIK
ARG003, Barracas, Ciudad Autónoma De BuenosAires, Argentina
Status
Address
ARG003
Barracas, Ciudad Autónoma De BuenosAires, C1280AEB
ARG007, Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Status
Address
ARG007
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, C1425BNG
ARG004, Villa Regina, Río Negro, Argentina
Status
Address
ARG004
Villa Regina, Río Negro, R8336
ARG001, Rosario, Santa Fe, Argentina
Status
Address
ARG001
Rosario, Santa Fe, S2002KDS
ARG002, San Miguel De Tucumán, Tucumán, Argentina
Status
Address
ARG002
San Miguel De Tucumán, Tucumán, T4000AXL
ARG008, Buenos Aires, Argentina
Status
Address
ARG008
Buenos Aires, , CI094AAD
AUS003, Camperdown, New South Wales, Australia
Status
Address
AUS003
Camperdown, New South Wales, 2050
AUS005, Macquarie Park, New South Wales, Australia