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A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
NCT06649110 · Novartis
In plain English
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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)
About this study
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.
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
Study design
Enrollment target: 232 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-10-24
Estimated completion: 2028-12-31
Last updated: 2026-03-09
Interventions
Drug: LTPDrug: Placebo
Primary outcomes
- • Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (Baseline to Day 35)
- • Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR) (Baseline to Week 24)
- • Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (From Day 1 until Week 106)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
All locations (29)
Stanford Medical CenterRecruiting
Stanford, California, United States
Univ Colorado HospitalRecruiting
Aurora, Colorado, United States
U of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Norton Infectious Diseases SpecialistsRecruiting
Louisville, Kentucky, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Summit Health Eastside ClinicRecruiting
Bend, Oregon, United States
Statcare Pulmonary ConsultantsRecruiting
Knoxville, Tennessee, United States
PPD Development LPRecruiting
Austin, Texas, United States
The University of UtahRecruiting
Salt Lake City, Utah, United States
Pul Ass Richmond Inc P A RRecruiting
Richmond, Virginia, United States
Novartis Investigative SiteRecruiting
Camperdown, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Porto Alegre, Rio Grande do Sul, Brazil
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Prague, Czechia
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Berlin, Germany
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Heidelberg, Germany
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Thessaloniki, Greece
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Sassari, SS, Italy
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Ivrea, TO, Italy
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Riga, Latvia
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Almada, Portugal
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Lisbon, Portugal
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Bucharest, Romania
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Toledo, Castille-La Mancha, Spain
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Las Palmas de Gran C, Las Palmas, Spain
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Barcelona, Spain
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Seville, Spain
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Cambridge, United Kingdom