A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Recruiting · NCT06649110 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
LTPPlacebo
What this trial is about
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- ther protocol-defined inclusion / exclusion criteria may apply
Where it is running
60 locations listed across 15 US states.
- 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
- 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 - Almada, Portugal
- Novartis Investigative Site - Athens, Greece
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Brest, France
- Novartis Investigative Site - Bucharest, Romania
- Novartis Investigative Site - CABA, Argentina
- Novartis Investigative Site - Cambridge, United Kingdom
- Novartis Investigative Site - Chaïdári, Greece
- Novartis Investigative Site - Clamart, France
- Novartis Investigative Site - Giessen, Germany
- Novartis Investigative Site - Greifswald, Germany
- Novartis Investigative Site - Grenoble, France
- Novartis Investigative Site - Heidelberg, Germany
- Novartis Investigative Site - Homburg, Germany
- Novartis Investigative Site - Kamenitz, Serbia
- Novartis Investigative Site - Lisbon, Portugal
- Novartis Investigative Site - London, United Kingdom
- Novartis Investigative Site - London, United Kingdom
- Novartis Investigative Site - Montpellier, France
- Novartis Investigative Site - Nice, France
- Novartis Investigative Site - Niš, Serbia
- Novartis Investigative Site - Pessac, France
- Novartis Investigative Site - Poitiers, France
- Novartis Investigative Site - Poznan, Poland
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Riga, Latvia
- Novartis Investigative Site - Río Cuarto, Argentina
- Novartis Investigative Site - Saint-Priest-en-Jarez, France
- Novartis Investigative Site - San Miguel de Tucumán, Argentina
- Novartis Investigative Site - Santa Fe, Argentina
- Novartis Investigative Site - Seville, Spain
- Novartis Investigative Site - Strasbourg, France
- Novartis Investigative Site - Thessaloniki, Greece
- Novartis Investigative Site - Toulouse, France
- Novartis Investigative Site - Vandœuvre-lès-Nancy, France
- Novartis Investigative Site - Santiago Compostela, A Coruna, Spain
- Novartis Investigative Site - Marbella, Andalusia, Spain
Showing 60 of 87 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →