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.
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
Darlinghurst,New South Wales,2010,Australia
Novartis Investigative Site
Recruiting
New Lambton Heights,New South Wales,2305,Australia
Novartis Investigative Site
Recruiting
Riga,Lv 1002,Latvia
Novartis Investigative Site
Recruiting
Lisbon,1769 001,Portugal
Novartis Investigative Site
Recruiting
Bucharest,050159,Romania
Stanford Medical Center
Recruiting
Stanford,California,94305,United States
Roham Zamanian
The Uni of Kansas Medical Center
Recruiting
Kansas City,Kansas,66160,United States
Leslie Spikes
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
John Ryan
Pul Ass Richmond Inc P A R
Recruiting
Richmond,Virginia,23230-1709,United States
Shilpa Johri
Worldwide Contacts
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