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
Novartis Investigative Site
Recruiting
Camperdown,New South Wales,2050,Australia
Novartis Investigative Site
Recruiting
New Lambton Heights,New South Wales,2305,Australia
Novartis Investigative Site
Recruiting
Darlinghurst,New South Wales,2010,Australia
Novartis Investigative Site
Recruiting
Porto Alegre,Rio Grande do Sul,90035-074,Brazil
Novartis Investigative Site
Recruiting
Prague,14021,Czechia
Novartis Investigative Site
Recruiting
Heidelberg,69120,Germany
Novartis Investigative Site
Recruiting
Berlin,14050,Germany
Novartis Investigative Site
Recruiting
Thessaloniki,54636,Greece
Novartis Investigative Site
Recruiting
Sassari,SS,07100,Italy
Novartis Investigative Site
Recruiting
Ivrea,TO,10015,Italy
Novartis Investigative Site
Recruiting
Riga,Lv 1002,Latvia
Novartis Investigative Site
Recruiting
Almada,2805-267,Portugal
Novartis Investigative Site
Recruiting
Lisbon,1769 001,Portugal
Novartis Investigative Site
Recruiting
Bucharest,050159,Romania
Novartis Investigative Site
Recruiting
Toledo,Castille-La Mancha,45071,Spain
Novartis Investigative Site
Recruiting
Barcelona,08035,Spain
Novartis Investigative Site
Recruiting
Las Palmas de Gran C,Las Palmas,35016,Spain
Novartis Investigative Site
Recruiting
Seville,41013,Spain
Novartis Investigative Site
Recruiting
Cambridge,Cb2 0ay,United Kingdom
Pul Ass Richmond Inc P A R
Recruiting
Richmond,Virginia,23230-1709,United States
Shilpa Johri
Stanford Medical Center
Recruiting
Stanford,California,94305,United States
Roham Zamanian
Norton Infectious Diseases Specialists
Recruiting
Louisville,Kentucky,40202,United States
John Wesley McConnell
The University of Utah
Recruiting
Salt Lake City,Utah,84132-0001,United States
Katharine Clapham
Summit Health Eastside Clinic
Recruiting
Bend,Oregon,97701,United States
Jeremy Feldman
U of Kansas Medical Center
Recruiting
Kansas City,Kansas,66160,United States
Leslie Spikes
Statcare Pulmonary Consultants
Recruiting
Knoxville,Tennessee,37919,United States
John Swisher
Tufts Medical Center
Recruiting
Boston,Massachusetts,02111,United States
Nicholas Hill
Univ Colorado Hospital
Recruiting
Aurora,Colorado,80045,United States
David B Badesch
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.