A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Sponsored by Novartis Pharmaceuticals
About this study
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
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.
Where this study is enrolling (16)
- Call (480) 614-2000
Arizona Pulmonary Specialists Ltd
Scottsdale, Arizona
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- Call +1 714 456 6037
UC Irvine Medical Center
Orange, California
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- Call +1 650 725 5495
Stanford Medical Center
Stanford, California
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- Call +1 720 848 6567
Univ Colorado Hospital
Aurora, Colorado
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- Call +1 813 844 7137
University of South Florida
Tampa, Florida
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Show all 16 locations
- Call +1 407 841 1100
Central Florida Pulmonary Group
Orlando, Florida
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- I'm interested
Emory University School of Medicine
Atlanta, Georgia
- Call +1 913 588 9722
U of Kansas Medical Center
Kansas City, Kansas
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- Call +1 502 587 8000
Norton Infectious Diseases Specialists
Louisville, Kentucky
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- Call +1 781 744 3874
Lahey Hospital and Medical Center
Burlington, Massachusetts
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- Call +1 617 636 4288
Tufts Medical Center
Boston, Massachusetts
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- Call +1 941 924 9800
Statcare Pulmonary Consultants
Knoxville, Tennessee
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- Call +1 512 447 2985
PPD Development LP
Austin, Texas
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- Call +1 214 645 6488
UT Southwestern Medical Center
Dallas, Texas
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- Call +1 801 213 4086
The University of Utah
Salt Lake City, Utah
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- Call +1 804 288 5945
Pul Ass Richmond Inc P A R
Richmond, Virginia
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Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.