What this study is
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
What's being tested
- LTP
Intervention · DRUG
LTP001
- Placebo
Intervention · DRUG
Placebo
Study details
- Official title
- 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
- Conditions
- Healthy Volunteers, Pulmonary Arterial Hypertension
- Enrolling
- 232 people
- Starts
- 2024-10-24
- Est. completion
- 2028-12-31
- Design
- Double-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers AcceptedPart A
You may qualify if
- Healthy males and non-child-bearing potential females
You can't join if
- 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
You may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (87)
87 openArizona Pulmonary Specialists Ltd
Scottsdale, Arizona, United States
- Contact+1 602 271 0832
- Akshay Muralidhar · Principal investigator
RecruitingUC Irvine Medical Center
Orange, California, United States
- Contact+1 714 456 6037
- Bassam Yaghmour · Principal investigator
RecruitingStanford Medical Center
Stanford, California, United States
- Contact+1 650 725 5495
- Roham Zamanian · Principal investigator
RecruitingUniv Colorado Hospital
Aurora, Colorado, United States
- Contact+1 720 848 6567
- David B Badesch · Principal investigator
RecruitingCentral Florida Pulmonary Group
Orlando, Florida, United States
- Contact+1 407 841 1100
- Syed Mobin · Principal investigator
RecruitingUniversity of South Florida
Tampa, Florida, United States
- Contact+1 813 844 7137
- Ricardo Restrepo-Jaramillo · Principal investigator
RecruitingEmory University School of Medicine
Atlanta, Georgia, United States
- Contact+1 404 778 3261
- Micah Fisher · Principal investigator
RecruitingU of Kansas Medical Center
Kansas City, Kansas, United States
- Contact+1 913 588 9722
- Leslie Spikes · Principal investigator
RecruitingNorton Infectious Diseases Specialists
Louisville, Kentucky, United States
- Contact+1 502 587 8000
- John Wesley McConnell · Principal investigator
RecruitingTufts Medical Center
Boston, Massachusetts, United States
- Contact+1 617 636 4288
- Nicholas Hill · Principal investigator
RecruitingLahey Hospital and Medical Center
Burlington, Massachusetts, United States
- Contact+1 781 744 3874
- Ioana Preston · Principal investigator
RecruitingSky Integrative Medical Center SKYCRNG PPDS
Ridgeland, Mississippi, United States
- Bob Hutchins · Principal investigator
RecruitingSummit Health Eastside Clinic
Bend, Oregon, United States
- Jeremy Feldman · Principal investigator
RecruitingAllegheny General Hospital
Pittsburgh, Pennsylvania, United States
- Hayah Kassis-George · Principal investigator
RecruitingStatcare Pulmonary Consultants
Knoxville, Tennessee, United States
- Contact+1 941 924 9800
- John Swisher · Principal investigator
RecruitingPPD Development LP
Austin, Texas, United States
- Contact+1 512 447 2985
- Jia Chang · Principal investigator
RecruitingPPD Development LP
Austin, Texas, United States
- Shawn Searle · Principal investigator
RecruitingUT Southwestern Medical Center
Dallas, Texas, United States
- Contact+1 214 645 6488
- Kelly Chin · Principal investigator
RecruitingThe University of Utah
Salt Lake City, Utah, United States
- Contact+1 801 213 4086
- Katharine Clapham · Principal investigator
RecruitingPul Ass Richmond Inc P A R
Richmond, Virginia, United States
- Contact+1 804 288 5945
- Shilpa Johri · Principal investigator
Recruiting
67 sites outside the US
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., Argentina
RecruitingNovartis Investigative Site
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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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
Recruiting
Study team
Sponsor
Novartis Pharmaceuticals
Study ID CLTP001A12202
Study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.