A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of LTP001 in Healthy Adult Participants (Part A) and to Evaluate the Efficacy and Safety of LTP001 for the Treatment of Participants With Pulmonary Arterial Hypertension (Part B)
Novartis Pharmaceuticals
Summary
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Description
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.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
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 Incl…
Interventions
- DrugLTP
LTP001
- DrugPlacebo
Placebo
Locations (85)
- Arizona Pulmonary Specialists LtdScottsdale, Arizona
- UC Irvine Medical CenterOrange, California
- Stanford Medical CenterStanford, California
- Univ Colorado HospitalAurora, Colorado
- Central Florida Pulmonary GroupOrlando, Florida
- University of South FloridaTampa, Florida