RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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)
About This Trial
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Who May Be Eligible (Plain English)
Part A Who May Qualify:
- Healthy males and non-child-bearing potential females
Part A Who Should NOT Join This Trial:
- 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 Who May Qualify:
-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 Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
LTP
LTP001
DRUG
Placebo
Placebo
Locations (20)
Stanford Medical Center
Stanford, California, United States
Univ Colorado Hospital
Aurora, Colorado, 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
Summit Health Eastside Clinic
Bend, Oregon, United States
Statcare Pulmonary Consultants
Knoxville, Tennessee, United States
PPD Development LP
Austin, 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
Camperdown, New South Wales, Australia
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
New Lambton Heights, New South Wales, Australia
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Thessaloniki, Greece
Novartis Investigative Site
Sassari, SS, Italy
Novartis Investigative Site
Ivrea, TO, Italy