Exploring the treatment LTP001 in healthy individuals and those with pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers in Part A, while Part B focuses on participants diagnosed with pulmonary arterial hypertension (PAH). The study aims to evaluate both the safety and efficacy of LTP001 in individuals with PAH, who are already receiving standard treatments. Participants will undergo assessments to determine the drug's effects on their condition and overall health. The study is designed to provide insights into how LTP001 can be used in treating PAH.

Why it matters

Who can join: the full rules

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

Where it's running

• Arizona Pulmonary Specialists Ltd
  Scottsdale, Arizona, United States Recruiting
• UC Irvine Medical Center
  Orange, California, United States Recruiting
• Stanford Medical Center
  Stanford, California, United States Recruiting
• Univ Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Central Florida Pulmonary Group
  Orlando, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting

+37 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating KK3910 in Healthy Volunteers and Patients with High Blood Pressure

  This study is testing the safety of a new medication called KK3910 in healthy young men and in patients with high blood pressure to see how it affects their health.

  Recruiting Phase 1 Kyowa Kirin Co., Ltd. · Hakata, Fukuoka and 2 other locations · NCT06823947

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.