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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

Novartis Pharmaceuticals · NCT06649110

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
232
US sites recruiting
20
Study start
October 24, 2024
Record last updated
July 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Being studied: LTP; Placebo

Conditions: Healthy Volunteers, Pulmonary Arterial Hypertension

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Arizona Pulmonary Specialists Ltd

    Scottsdale, AZ 85258

    Site contact: +1 602 271 0832

  • UC Irvine Medical Center

    Orange, CA 92868-3298

    Site contact: +1 714 456 6037

  • Stanford Medical Center

    Stanford, CA 94305

    Site contact: +1 650 725 5495

  • Univ Colorado Hospital

    Aurora, CO 80045

    Site contact: +1 720 848 6567

  • Central Florida Pulmonary Group

    Orlando, FL 32803-5734

    Site contact: +1 407 841 1100

  • University of South Florida

    Tampa, FL 33606-3475

    Site contact: +1 813 844 7137

  • Emory University School of Medicine

    Atlanta, GA 30322

    Site contact: +1 404 778 3261

  • U of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: +1 913 588 9722

  • Norton Infectious Diseases Specialists

    Louisville, KY 40202

    Site contact: +1 502 587 8000

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: +1 617 636 4288

  • Lahey Hospital and Medical Center

    Burlington, MA 01805

    Site contact: +1 781 744 3874

  • Sky Integrative Medical Center SKYCRNG PPDS

    Ridgeland, MS 39157-5179

    Site contact: Bob Hutchins

  • Summit Health Eastside Clinic

    Bend, OR 97701

    Site contact: Jeremy Feldman

  • Allegheny General Hospital

    Pittsburgh, PA 15212-4756

    Site contact: Hayah Kassis-George

  • Statcare Pulmonary Consultants

    Knoxville, TN 37919

    Site contact: +1 941 924 9800

  • PPD Development LP

    Austin, TX 78744

    Site contact: +1 512 447 2985

  • PPD Development LP

    Austin, TX 78744

    Site contact: Shawn Searle

  • UT Southwestern Medical Center

    Dallas, TX 75390

    Site contact: +1 214 645 6488

  • The University of Utah

    Salt Lake City, UT 84132-0001

    Site contact: +1 801 213 4086

  • Pul Ass Richmond Inc P A R

    Richmond, VA 23230-1709

    Site contact: +1 804 288 5945

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
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