Summary

Eligibility
for people ages 18-100 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Bassam Yaghmour

Description

Summary

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

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)

Details

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.

Keywords

Healthy Volunteers, Pulmonary Arterial Hypertension, LTP001, pulmonary arterial hypertension, PAH, PVR, LTP

Eligibility

For people ages 18-100

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

Locations

  • UC Irvine Medical Center accepting new patients
    Orange California 92868-3298 United States
  • Arizona Pulmonary Specialists Ltd accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist at UC Irvine

  • Bassam Yaghmour
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 14 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT06649110
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 232 study participants
Last Updated