Clinical Trials in Spain / NCT06649110
Recruiting
Phase 1/2
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
NCT06649110 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Healthy Volunteers, Pulmonary Arterial Hypertension
Investigational drug(s) / intervention(s)
LTPPlacebo
LTP: LTP001
Placebo: Placebo
Study summary
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Eligibility
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
Primary outcome measure(s)
- Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) — Baseline to Day 35
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit. - Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR) — Baseline to Week 24
PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. - Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) — From Day 1 until Week 106
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.
Trial sites (87)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Pulmonary Specialists Ltd | Scottsdale | Arizona | Recruiting |
| UC Irvine Medical Center | Orange | California | Recruiting |
| Stanford Medical Center | Stanford | California | Recruiting |
| Univ Colorado Hospital | Aurora | Colorado | Recruiting |
| Central Florida Pulmonary Group | Orlando | Florida | Recruiting |
| University of South Florida | Tampa | Florida | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | Recruiting |
| U of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Norton Infectious Diseases Specialists | Louisville | Kentucky | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Recruiting |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | Recruiting |
| Sky Integrative Medical Center SKYCRNG PPDS | Ridgeland | Mississippi | Recruiting |
| Summit Health Eastside Clinic | Bend | Oregon | Recruiting |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | Recruiting |
| Statcare Pulmonary Consultants | Knoxville | Tennessee | Recruiting |
| PPD Development LP | Austin | Texas | Recruiting |
| PPD Development LP | Austin | Texas | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| The University of Utah | Salt Lake City | Utah | Recruiting |
| Pul Ass Richmond Inc P A R | Richmond | Virginia | Recruiting |
| Novartis Investigative Site | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Novartis Investigative Site | CABA | Argentina | Recruiting |
| Novartis Investigative Site | Río Cuarto | Argentina | Recruiting |
| Novartis Investigative Site | San Miguel de Tucumán | Argentina | Recruiting |
| Novartis Investigative Site | Santa Fe | Argentina | Recruiting |
| Novartis Investigative Site | Camperdown | New South Wales | Recruiting |
| Novartis Investigative Site | Darlinghurst | New South Wales | Recruiting |
| Novartis Investigative Site | New Lambton Heights | New South Wales | Recruiting |
| Novartis Investigative Site | Adelaide | South Australia | Recruiting |
| Novartis Investigative Site | Leuven | Vlaams Brabant | Recruiting |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | Recruiting |
| Novartis Investigative Site | Prague | Czechia | Recruiting |
| Novartis Investigative Site | Prague | Czechia | Recruiting |
| Novartis Investigative Site | Angers | France | Recruiting |
| Novartis Investigative Site | Brest | France | Recruiting |
| Novartis Investigative Site | Clamart | France | Recruiting |
| Novartis Investigative Site | Grenoble | France | Recruiting |
| Novartis Investigative Site | Montpellier | France | Recruiting |
| Novartis Investigative Site | Nice | France | Recruiting |
| Novartis Investigative Site | Pessac | France | Recruiting |
+ 47 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Spain
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06649110 on ClinicalTrials.gov ↗ ← All trials in Spain