A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
- Conditions
- Healthy Volunteers, Pulmonary Arterial Hypertension
- Interventions
- Drug: LTPDrug: Placebo
- Registration Number
- NCT06649110
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 232
- Healthy males and non-child-bearing potential females
Part A
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LTP001 Dose 1 LTP - LTP001 Dose 2 LTP - LTP001 Dose 3 LTP - Placebo Placebo matching placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 activityPart 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
Trial Locations
- Locations (1)
PPD Development LP
🇺🇸Austin, Texas, United States