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

NCT06649110

RecruitingPhase 1, Phase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Healthy Volunteers, Pulmonary Arterial Hypertension

Interventions: LTP, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Czechia, France, Germany

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (87)

Scottsdale, Arizona, United States
Orange, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Ridgeland, Mississippi, United States
Bend, Oregon, United States
Pittsburgh, Pennsylvania, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Buenos Aires, Buenos Aires F.D., Argentina
CABA, Argentina
Río Cuarto, Argentina
San Miguel de Tucumán, Argentina
Santa Fe, Argentina
Camperdown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Adelaide, South Australia, Australia
Leuven, Vlaams Brabant, Belgium
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