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
Worldwide Contacts
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