Study Description
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B) The CLTP001A12202 study will explore the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers (Part A) and will evaluate the safety and efficacy (Part B) followed by safety extension in participants with pulmonary arterial hypertension.
Interventions
LTP
Placebo
Eligibility Criteria
Part A Inclusion Criteria:
* Healthy males and non-child-bearing potential females
Part A Exclusion Criteria:
* Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply.
* For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol.
Part B Inclusion Criteria:
-Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.
Part B Exclusion Criteria:
Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.
History of hypersensitivity to any of the study treatments or excipients
Other protocol-defined inclusion / exclusion criteria may apply
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San Miguel de Tucumán,4000,Argentina
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Río Cuarto,X5800aev,Argentina
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CABA,C1426abp,Argentina
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Buenos Aires,Buenos Aires F.D.,1199,Argentina
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Santa Fe,S3000eoz,Argentina
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New Lambton Heights,New South Wales,2305,Australia
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Camperdown,New South Wales,2050,Australia
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Adelaide,South Australia,5000,Australia
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Darlinghurst,New South Wales,2010,Australia
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Leuven,Vlaams Brabant,3000,Belgium
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Porto Alegre,Rio Grande do Sul,90035-074,Brazil
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Prague,128 08,Czechia
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Prague,14021,Czechia
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Toulouse,31059,France
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Pessac,33604,France
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Vandœuvre-lès-Nancy,54511,France
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Strasbourg,67091,France
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Saint-Priest-en-Jarez,42270,France
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Poitiers,86021,France
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Angers,France,49933,France
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Nice,06001,France
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Montpellier,34295,France
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Brest,29200,France
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Clamart,92141,France
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Grenoble,38043,France
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Dresden,Saxony,01307,Germany
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Berlin,13125,Germany
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Giessen,35392,Germany
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Greifswald,17475,Germany
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Homburg,66421,Germany
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Regensburg,Bavaria,93053,Germany
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Heidelberg,69120,Germany
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Berlin,14050,Germany
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Thessaloniki,54636,Greece
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Chaïdári,124 62,Greece
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Athens,106 76,Greece
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Sassari,SS,07100,Italy
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Palermo,PA,90127,Italy
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Monza,MB,20900,Italy
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Foggia,FG,71122,Italy
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Pavia,PV,27100,Italy
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Roma,RM,00161,Italy
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Trieste,TS,34149,Italy
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Ivrea,TO,10015,Italy
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Riga,Lv 1002,Latvia
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San Luis Potosí City,San Luis Potosí,78200,Mexico
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Monterrey,Nuevo León,64460,Mexico
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Poznan,61 545,Poland
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Lisbon,1769 001,Portugal
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Almada,2805-267,Portugal
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Bucharest,050159,Romania
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Timișoara,Timiș County,300310,Romania
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Kamenitz,21204,Serbia
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Niš,18108,Serbia
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Belgrade,Serbia,11000,Serbia
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Las Palmas de Gran C,Las Palmas,35016,Spain
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Seville,41013,Spain
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Toledo,Castille-La Mancha,45071,Spain
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Barcelona,08035,Spain
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Santiago Compostela,A Coruna,15706,Spain
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Marbella,Andalusia,29600,Spain
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Barcelona,Catalonia,08003,Spain
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Cambridge,Cb2 0ay,United Kingdom
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Sheffield,South Yorkshire,S10 2jf,United Kingdom
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London,Ec1a 7be,United Kingdom
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London,Sw3 6ph,United Kingdom
Allegheny General Hospital
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Pittsburgh,Pennsylvania,15212-4756,United States
Hayah Kassis-George
Statcare Pulmonary Consultants
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Knoxville,Tennessee,37919,United States
John Swisher
Stanford Medical Center
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Stanford,California,94305,United States
Roham Zamanian
Norton Infectious Diseases Specialists
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Louisville,Kentucky,40202,United States
John Wesley McConnell
The University of Utah
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Salt Lake City,Utah,84132-0001,United States
Katharine Clapham
Pul Ass Richmond Inc P A R
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Richmond,Virginia,23230-1709,United States
Shilpa Johri
U of Kansas Medical Center
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Kansas City,Kansas,66160,United States
Leslie Spikes
Summit Health Eastside Clinic
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Bend,Oregon,97701,United States
Jeremy Feldman
Univ Colorado Hospital
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Aurora,Colorado,80045,United States
David B Badesch
Tufts Medical Center
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Boston,Massachusetts,02111,United States
Nicholas Hill
UT Southwestern Medical Center
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Dallas,Texas,75390,United States
Kelly Chin
Arizona Pulmonary Specialists Ltd
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Scottsdale,Arizona,85258,United States
Akshay Muralidhar
UC Irvine Medical Center
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Orange,California,92868-3298,United States
Bassam Yaghmour
Central Florida Pulmonary Group
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Orlando,Florida,32803-5734,United States
Syed Mobin
University of South Florida
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Tampa,Florida,33606-3475,United States
Ricardo Restrepo-Jaramillo
Emory University School of Medicine
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Atlanta,Georgia,30322,United States
Micah Fisher
Lahey Hospital and Medical Center
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Burlington,Massachusetts,01805,United States
Ioana Preston
Sky Integrative Medical Center SKYCRNG PPDS
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Ridgeland,Mississippi,39157-5179,United States
Bob Hutchins
Worldwide Contacts
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