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Набира участници Фаза 1/2 NCT06649110

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

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Healthy Volunteers, Pulmonary Arterial Hypertension

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Описание
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.
Кой може да участва
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
Места на провеждане 12
Австралия (1)
Novartis Investigative Site
Camperdown , New South Wales
Бразилия (1)
Novartis Investigative Site
Porto Alegre , Rio Grande do Sul
Чехия (1)
Novartis Investigative Site
Prague
Германия (1)
Novartis Investigative Site
Berlin
Гърция (1)
Novartis Investigative Site
Thessaloniki
Италия (1)
Novartis Investigative Site
Sassari , SS
Latvia (1)
Novartis Investigative Site
Riga
Португалия (1)
Novartis Investigative Site
Almada
Румъния (1)
Novartis Investigative Site
Bucharest
Испания (1)
Novartis Investigative Site
Toledo , Castille-La Mancha
Великобритания (1)
Novartis Investigative Site
Cambridge
САЩ (1)
Stanford Medical Center
Stanford , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
100 Years
Здрави доброволци
Не
Начална дата
24.10.2024
Крайна дата
31.12.2028
Регистрационен номер
NCT06649110
Източник
anzctr
Запитване за медицински туризъм

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