Healthy Volunteers, Pulmonary Arterial Hypertension
Conditions
Keywords
LTP001, pulmonary arterial hypertension, PAH, PVR
Brief summary
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Detailed description
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.
Interventions
DRUGLTP
LTP001
DRUGPlacebo
Placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) | Baseline to Day 35 | Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit. |
| Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR) | Baseline to Week 24 | PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. |
| Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) | From Day 1 until Week 106 | Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A- Maximum observed plasma concentrations (Cmax) | Baseline to Day 35 | Cmax is defined as the maximum (peak) observed concentration following a dose. |
| Part A- Time to reach maximum plasma concentration (Tmax) | Baseline to Day 35 | Tmax is defined as the time to reach maximum (peak) concentration following a dose. |
| Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) | Baseline to Day 35 | AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast). |
| Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) | Baseline to Day 35 | The AUC is the area under the plasma concentration from time zero to infinity (mass x time x volume-1). |
| Part A- Terminal elimination half-life (T1/2) | Baseline to Day 35 | T1/2 is the elimination half-life associated with the terminal slope. |
| Part B-Treatment Period 1: Change in the Six-minute Walk Test (6MWT) | Baseline to Week 24 | The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. |
| Part B-Treatment Period 1: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) | Baseline to Week 24 | N-terminal pro brain natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder, as in heart failure. |
| Part B-Treatment Period 1: Change in World Health Organization (WHO) functional class (FC) | Baseline to Week 24 | The Investigator or study staff will assign a WHO functional class to a participant based on reports of symptoms and activity limitation. * Class I: symptom-free when physically active or resting. * Class II: no symptoms at rest, but normal activities such as climbing the stairs, grocery shopping, or making the bed cause some discomfort and shortness of breath. * Class III: resting may be symptom-free, but normal chores around the house are greatly limited due to shortness of breath and feeling tired. * Class IV: symptoms at rest and severe symptoms with an activity |
| Part B-Treatment Period 2: Change in the Six-minute Walk Test (6MWT) | Baseline to Month 18 | The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. |
| Part B-Treatment Period 2: Change in World Health Organization (WHO) functional class (FC) | Baseline to Month 18 | The Investigator or study staff will assign a WHO functional class to a participant based on reports of symptoms and activity limitation. * Class I: symptom-free when physically active or resting. * Class II: no symptoms at rest, but normal activities such as climbing the stairs, grocery shopping, or making the bed cause some discomfort and shortness of breath. * Class III: resting may be symptom-free, but normal chores around the house are greatly limited due to shortness of breath and feeling tired. * Class IV: symptoms at rest and severe symptoms with an activity |
Countries
Argentina, Australia, Belgium, Brazil, Czechia, France, Germany, Greece, Italy, Latvia, Mexico, Poland, Portugal, Romania, Serbia, Spain, United Kingdom, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed