A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LTP, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers, Pulmonary Arterial Hypertension. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +13
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Detailed 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.
Interventions
- Drug LTP
LTP001 - Drug Placebo
Placebo
Primary outcome measures
- Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) [Time frame: Baseline to Day 35]
- Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR) [Time frame: Baseline to Week 24]
- Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) [Time frame: From Day 1 until Week 106]
Secondary outcome measures (10)
- Part A- Maximum observed plasma concentrations (Cmax) [Time frame: Baseline to Day 35]
- Part A- Time to reach maximum plasma concentration (Tmax) [Time frame: Baseline to Day 35]
- Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) [Time frame: Baseline to Day 35]
- Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) [Time frame: Baseline to Day 35]
- Part A- Terminal elimination half-life (T1/2) [Time frame: Baseline to Day 35]
- Part B-Treatment Period 1: Change in the Six-minute Walk Test (6MWT) [Time frame: Baseline to Week 24]
- Part B-Treatment Period 1: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) [Time frame: Baseline to Week 24]
- Part B-Treatment Period 1: Change in World Health Organization (WHO) functional class (FC) [Time frame: Baseline to Week 24]
- Part B-Treatment Period 2: Change in the Six-minute Walk Test (6MWT) [Time frame: Baseline to Month 18]
- Part B-Treatment Period 2: Change in World Health Organization (WHO) functional class (FC) [Time frame: Baseline to Month 18]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Arizona Pulmonary Specialists Ltd — Scottsdale
- UC Irvine Medical Center — Orange
- Stanford Medical Center — Stanford
- Univ Colorado Hospital — Aurora
- Central Florida Pulmonary Group — Orlando
- University of South Florida — Tampa
- Emory University School of Medicine — Atlanta
- U of Kansas Medical Center — Kansas City
- … and 12 more centers
France · 12 centers
- Novartis Investigative Site — Angers
- Novartis Investigative Site — Brest
- Novartis Investigative Site — Clamart
- Novartis Investigative Site — Grenoble
- Novartis Investigative Site — Montpellier
- Novartis Investigative Site — Nice
- Novartis Investigative Site — Pessac
- Novartis Investigative Site — Poitiers
- … and 4 more centers
Germany · 8 centers
- Novartis Investigative Site — Regensburg
- Novartis Investigative Site — Dresden
- Novartis Investigative Site — Berlin
- Novartis Investigative Site — Berlin
- Novartis Investigative Site — Giessen
- Novartis Investigative Site — Greifswald
- Novartis Investigative Site — Heidelberg
- Novartis Investigative Site — Homburg
Italy · 8 centers
- Novartis Investigative Site — Foggia
- Novartis Investigative Site — Monza
- Novartis Investigative Site — Palermo
- Novartis Investigative Site — Pavia
- Novartis Investigative Site — Roma
- Novartis Investigative Site — Sassari
- Novartis Investigative Site — Ivrea
- Novartis Investigative Site — Trieste
Spain · 7 centers
- Novartis Investigative Site — Santiago Compostela
- Novartis Investigative Site — Marbella
- Novartis Investigative Site — Toledo
- Novartis Investigative Site — Barcelona
- … and 3 more centers
Argentina · 5 centers
- Novartis Investigative Site — Buenos Aires
- Novartis Investigative Site — CABA
- Novartis Investigative Site — Río Cuarto
- Novartis Investigative Site — San Miguel de Tucumán
- Novartis Investigative Site — Santa Fe
Australia · 4 centers
- Novartis Investigative Site — Camperdown
- Novartis Investigative Site — Darlinghurst
- Novartis Investigative Site — New Lambton Heights
- Novartis Investigative Site — Adelaide
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Greece · 3 centers
- Novartis Investigative Site — Athens
- Novartis Investigative Site — Chaïdári
- Novartis Investigative Site — Thessaloniki
Mexico · 3 centers
- Novartis Investigative Site — Monterrey
- Novartis Investigative Site — Monterrey
- Novartis Investigative Site — San Luis Potosí City
Serbia · 3 centers
- Novartis Investigative Site — Belgrade
- Novartis Investigative Site — Kamenitz
- Novartis Investigative Site — Niš
Czechia · 2 centers
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Prague
Portugal · 2 centers
- Novartis Investigative Site — Almada
- Novartis Investigative Site — Lisbon
Romania · 2 centers
- Novartis Investigative Site — Timișoara
- Novartis Investigative Site — Bucharest
Belgium · 1 center
- Novartis Investigative Site — Leuven
Brazil · 1 center
- Novartis Investigative Site — Porto Alegre
Latvia · 1 center
- Novartis Investigative Site — Riga
Poland · 1 center
- Novartis Investigative Site — Poznan
Identifiers
NCT: NCT06649110 · CLTP001A12202