🔎 Trials Near Me

Home › Pulmonary Arterial Hypertension › NCT06649110

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

RecruitingPhase 1/2Healthy volunteers welcome

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)

Who can join

Ages 18 to 100 · All sexes · Healthy volunteers welcome

Full 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

About the study

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

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 232 · Started: Oct 24, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06649110

Locations in the U.S.

ArizonaArizona Pulmonary Specialists Ltd, Scottsdale
CaliforniaUC Irvine Medical Center, Orange
Stanford Medical Center, Stanford
ColoradoUniv Colorado Hospital, Aurora
FloridaCentral Florida Pulmonary Group, Orlando
University of South Florida, Tampa
GeorgiaEmory University School of Medicine, Atlanta
KansasU of Kansas Medical Center, Kansas City
KentuckyNorton Infectious Diseases Specialists, Louisville
MassachusettsTufts Medical Center, Boston
Lahey Hospital and Medical Center, Burlington
MississippiSky Integrative Medical Center SKYCRNG PPDS, Ridgeland
OregonSummit Health Eastside Clinic, Bend
PennsylvaniaAllegheny General Hospital, Pittsburgh
TennesseeStatcare Pulmonary Consultants, Knoxville
TexasPPD Development LP, Austin
PPD Development LP, Austin
UT Southwestern Medical Center, Dallas
UtahThe University of Utah, Salt Lake City
VirginiaPul Ass Richmond Inc P A R, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.