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Recruiting Phase 1/2 NCT06649110

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

Phase 1/2 – combined early trial
Conditions: Healthy Volunteers, Pulmonary Arterial Hypertension

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Description
The CLTP001A12202 study will explore the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers (Part A) and will evaluate the safety and efficacy (Part B) followed by safety extension in participants with pulmonary arterial hypertension.
Who can participate
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 12
Australia (1)
Novartis Investigative Site
Camperdown , New South Wales
Brazil (1)
Novartis Investigative Site
Porto Alegre , Rio Grande do Sul
Czech Republic (1)
Novartis Investigative Site
Prague
Germany (1)
Novartis Investigative Site
Berlin
Greece (1)
Novartis Investigative Site
Thessaloniki
Italy (1)
Novartis Investigative Site
Sassari , SS
Latvia (1)
Novartis Investigative Site
Riga
Portugal (1)
Novartis Investigative Site
Almada
Romania (1)
Novartis Investigative Site
Bucharest
Spain (1)
Novartis Investigative Site
Toledo , Castille-La Mancha
United Kingdom (1)
Novartis Investigative Site
Cambridge
United States (1)
Stanford Medical Center
Stanford , California
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
24.10.2024
Completion date
31.12.2028
Registry ID
NCT06649110
Source
anzctr
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