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NCT06649110PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

Novartis Pharmaceuticals

Start Date

10/24/2024

Completion Date

12/31/2028

Summary

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

Detailed 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 Criteria

Age Range: 18 years to 100 years

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

Interventions

DRUG

LTP

DRUG

Placebo

Interested in This Trial?

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Conditions

Healthy Volunteers, Pulmonary Arterial Hypertension

Locations

Arizona Pulmonary Specialists Ltd

Scottsdale, Arizona 85258

United States

UC Irvine Medical Center

Orange, California 92868-3298

United States

Stanford Medical Center

Stanford, California 94305

United States

Univ Colorado Hospital

Aurora, Colorado 80045

United States

Central Florida Pulmonary Group

Orlando, Florida 32803-5734

United States

University of South Florida

Tampa, Florida 33606-3475

United States

Emory University School of Medicine

Atlanta, Georgia 30322

United States

U of Kansas Medical Center

Kansas City, Kansas 66160

United States

Norton Infectious Diseases Specialists

Louisville, Kentucky 40202

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts 01805

United States

Sky Integrative Medical Center SKYCRNG PPDS

Ridgeland, Mississippi 39157-5179

United States

Summit Health Eastside Clinic

Bend, Oregon 97701

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212-4756

United States

Statcare Pulmonary Consultants

Knoxville, Tennessee 37919

United States

PPD Development LP

Austin, Texas 78744

United States

PPD Development LP

Austin, Texas 78744

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

The University of Utah

Salt Lake City, Utah 84132-0001

United States

Pul Ass Richmond Inc P A R

Richmond, Virginia 23230-1709

United States

Novartis Investigative Site

Buenos Aires, Buenos Aires F.D. 1199

Argentina

Novartis Investigative Site

CABA, C1426ABP

Argentina

Novartis Investigative Site

Río Cuarto, X5800AEV

Argentina

Novartis Investigative Site

San Miguel de Tucumán, T4000AXL

Argentina

Novartis Investigative Site

Santa Fe, S3000EOZ

Argentina

Novartis Investigative Site

Camperdown, New South Wales 2050

Australia

Novartis Investigative Site

Darlinghurst, New South Wales 2010

Australia

Novartis Investigative Site

New Lambton Heights, New South Wales 2305

Australia

Novartis Investigative Site

Adelaide, South Australia 5000

Australia

Novartis Investigative Site

Leuven, Vlaams Brabant 3000

Belgium

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul 90035-074

Brazil

Novartis Investigative Site

Prague, 128 08

Czechia

Novartis Investigative Site

Prague, 14021

Czechia

Novartis Investigative Site

Angers, France 49933

France

Novartis Investigative Site

Brest, 29200

France

Novartis Investigative Site

Clamart, 92141

France

Novartis Investigative Site

Grenoble, 38043

France

Novartis Investigative Site

Montpellier, 34295

France

Novartis Investigative Site

Nice, 06001

France

Novartis Investigative Site

Pessac, 33604

France

Novartis Investigative Site

Poitiers, 86021

France

Novartis Investigative Site

Saint-Priest-en-Jarez, 42270

France

Novartis Investigative Site

Strasbourg, 67091

France

Novartis Investigative Site

Toulouse, 31059

France

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511

France

Novartis Investigative Site

Regensburg, Bavaria 93053

Germany

Novartis Investigative Site

Dresden, Saxony 01307

Germany

Novartis Investigative Site

Berlin, 13125

Germany

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Berlin, 14050

Germany

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Giessen, 35392

Germany

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Greifswald, 17475

Germany

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Heidelberg, 69120

Germany

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Homburg, 66421

Germany

Novartis Investigative Site

Athens, 106 76

Greece

Novartis Investigative Site

Chaïdári, 124 62

Greece

Novartis Investigative Site

Thessaloniki, 54636

Greece

Novartis Investigative Site

Foggia, FG 71122

Italy

Novartis Investigative Site

Monza, MB 20900

Italy

Novartis Investigative Site

Palermo, PA 90127

Italy

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Pavia, PV 27100

Italy

Novartis Investigative Site

Roma, RM 00161

Italy

Novartis Investigative Site

Sassari, SS 07100

Italy

Novartis Investigative Site

Ivrea, TO 10015

Italy

Novartis Investigative Site

Trieste, TS 34149

Italy

Novartis Investigative Site

Riga, LV 1002

Latvia

Novartis Investigative Site

Monterrey, Nuevo León 64460

Mexico

Novartis Investigative Site

Monterrey, Nuevo León 64718

Mexico

Novartis Investigative Site

San Luis Potosí City, San Luis Potosí 78200

Mexico

Novartis Investigative Site

Poznan, 61 545

Poland

Novartis Investigative Site

Almada, 2805-267

Portugal

Novartis Investigative Site

Lisbon, 1769 001

Portugal

Novartis Investigative Site

Timișoara, Timiș County 300310

Romania

Novartis Investigative Site

Bucharest, 050159

Romania

Novartis Investigative Site

Belgrade, Serbia 11000

Serbia

Novartis Investigative Site

Kamenitz, 21204

Serbia

Novartis Investigative Site

Niš, 18108

Serbia

Novartis Investigative Site

Santiago Compostela, A Coruna 15706

Spain

Novartis Investigative Site

Marbella, Andalusia 29600

Spain

Novartis Investigative Site

Toledo, Castille-La Mancha 45071

Spain

Novartis Investigative Site

Barcelona, Catalonia 08003

Spain

Novartis Investigative Site

Las Palmas de Gran C, Las Palmas 35016

Spain

Novartis Investigative Site

Barcelona, 08035

Spain

Novartis Investigative Site

Seville, 41013

Spain

Novartis Investigative Site

Sheffield, South Yorkshire S10 2JF

United Kingdom

Novartis Investigative Site

Cambridge, CB2 0AY

United Kingdom

Novartis Investigative Site

London, EC1A 7BE

United Kingdom

Novartis Investigative Site

London, SW3 6PH

United Kingdom