NCT06649110RecruitingPhase 1/2
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
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)
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 17 Oct 2024
- Start date
- 24 Oct 2024
- Primary completion date
- 29 Nov 2028
- Lead sponsor
- Novartis Pharmaceuticals
- NCT number
- NCT06649110
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 232
- From 24 Oct 2024 to the primary completion date, 29 Nov 2028
- 81 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (81)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Santa Fe | Argentina | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Las Palmas de Gran C | Spain | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Marbella | Spain | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Santiago Compostela | Spain | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Clamart | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Foggia | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Ivrea | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Almada | Portugal | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Kamenitz | Serbia | Recruiting |
| Novartis Investigative Site Coordinator of this site? Confirm its status | Niš | Serbia | Recruiting |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Univ Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| PPD Development, LP Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Summit Health Eastside Clinic Coordinator of this site? Confirm its status | Bend | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Lahey Hospital and Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| U of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Statcare Pulmonary Consultants Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Norton Infectious Diseases Specialists Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| UC Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Central Florida Pulmonary Group Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Pul Ass Richmond Inc P A R Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Sky Integrative Medical Center SKYCRNG PPDS Coordinator of this site? Confirm its status | Ridgeland | United States | Recruiting |
| The University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Arizona Pulmonary Specialists Ltd Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Stanford Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.