RecruitingPhase 1Phase 2NCT06649110

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)

Sponsor

Novartis Pharmaceuticals

Enrollment

232 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers, Pulmonary Arterial Hypertension

Summary

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This two-part study is first testing a new drug called LTP001 in healthy volunteers to assess safety and how the body processes it, then testing it in patients with pulmonary arterial hypertension (PAH) — a serious condition where the blood pressure in the lungs is dangerously high, making it hard to breathe and putting strain on the heart. **You may be eligible if (Part A – healthy volunteers)...** - You are a healthy male or a female who cannot become pregnant - You have no significant heart or medical conditions **You may be eligible if (Part B – PAH patients)...** - You have a confirmed diagnosis of pulmonary arterial hypertension - Your lung vascular resistance is elevated (≥400 dyn·sec·cm⁻⁵) - You are on stable standard PAH medications - You can walk 150–450 meters in 6 minutes **You may NOT be eligible if...** - You have significant heart rhythm problems or cardiac abnormalities - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLTP

LTP001

DRUGPlacebo

Placebo

Locations(85)

Arizona Pulmonary Specialists Ltd

Scottsdale, Arizona, United States

UC Irvine Medical Center

Orange, California, United States

Stanford Medical Center

Stanford, California, United States

Univ Colorado Hospital

Aurora, Colorado, United States

Central Florida Pulmonary Group

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

U of Kansas Medical Center

Kansas City, Kansas, United States

Norton Infectious Diseases Specialists

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Sky Integrative Medical Center SKYCRNG PPDS

Ridgeland, Mississippi, United States

Summit Health Eastside Clinic

Bend, Oregon, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Statcare Pulmonary Consultants

Knoxville, Tennessee, United States

PPD Development LP

Austin, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

The University of Utah

Salt Lake City, Utah, United States

Pul Ass Richmond Inc P A R

Richmond, Virginia, United States

Novartis Investigative Site

Buenos Aires, Buenos Aires F.D., Argentina

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CABA, Argentina

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Río Cuarto, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Camperdown, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Adelaide, South Australia, Australia

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Leuven, Vlaams Brabant, Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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Prague, Czechia

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Prague, Czechia

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Angers, France, France

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Brest, France

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Clamart, France

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Grenoble, France

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Montpellier, France

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Nice, France

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Pessac, France

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Poitiers, France

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Saint-Priest-en-Jarez, France

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Strasbourg, France

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Toulouse, France

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Vandœuvre-lès-Nancy, France

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Regensburg, Bavaria, Germany

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Dresden, Saxony, Germany

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Berlin, Germany

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Berlin, Germany

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Giessen, Germany

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Greifswald, Germany

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Heidelberg, Germany

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Homburg, Germany

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Athens, Greece

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Chaïdári, Greece

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Thessaloniki, Greece

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Foggia, FG, Italy

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Monza, MB, Italy

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Palermo, PA, Italy

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Pavia, PV, Italy

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Roma, RM, Italy

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Sassari, SS, Italy

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Ivrea, TO, Italy

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Trieste, TS, Italy

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Riga, Latvia

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Monterrey, Nuevo León, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Poznan, Poland

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Almada, Portugal

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Lisbon, Portugal

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Timișoara, Timiș County, Romania

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Bucharest, Romania

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Belgrade, Serbia, Serbia

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Kamenitz, Serbia

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Niš, Serbia

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Santiago Compostela, A Coruna, Spain

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Marbella, Andalusia, Spain

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Toledo, Castille-La Mancha, Spain

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Barcelona, Catalonia, Spain

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Las Palmas de Gran C, Las Palmas, Spain

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Barcelona, Spain

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Seville, Spain

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Sheffield, South Yorkshire, United Kingdom

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Cambridge, United Kingdom

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London, United Kingdom

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London, United Kingdom

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NCT06649110