Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
232 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for healthy volunteers and patients diagnosed with pulmonary arterial hypertension (PAH). Participants will receive treatment LTP001 and help researchers learn about its effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am a healthy male or a female who cannot have children.
I have a confirmed diagnosis of pulmonary arterial hypertension (PAH).
I have a 6-minute walk distance of 150 to 450 meters.
I am stable on my current PAH therapies.
You may not be able to join if
I have significant heart problems or other serious medical issues.
I am a woman who can have children and not using effective birth control.
I am a sexually active male and unwilling to use a condom during the study.
I have a history of allergic reactions to any study treatments.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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, o…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
