A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
232
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.
Time frame: Baseline to Day 35
Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.
Time frame: Baseline to Week 24
Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.
Time frame: From Day 1 until Week 106
Part A- Maximum observed plasma concentrations (Cmax)
Cmax is defined as the maximum (peak) observed concentration following a dose.
Time frame: Baseline to Day 35
Part A- Time to reach maximum plasma concentration (Tmax)
Tmax is defined as the time to reach maximum (peak) concentration following a dose.
Time frame: Baseline to Day 35
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast).
Time frame: Baseline to Day 35
Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
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Arizona Pulmonary Specialists Ltd
Scottsdale, Arizona, United States
RECRUITINGUC Irvine Medical Center
Orange, California, United States
RECRUITINGStanford Medical Center
Stanford, California, United States
RECRUITINGUniv Colorado Hospital
Aurora, Colorado, United States
RECRUITINGCentral Florida Pulmonary Group
Orlando, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGEmory University School of Medicine
Atlanta, Georgia, United States
RECRUITINGU of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGNorton Infectious Diseases Specialists
Louisville, Kentucky, United States
RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
RECRUITING...and 77 more locations
The AUC is the area under the plasma concentration from time zero to infinity (mass x time x volume-1).
Time frame: Baseline to Day 35
Part A- Terminal elimination half-life (T1/2)
T1/2 is the elimination half-life associated with the terminal slope.
Time frame: Baseline to Day 35
Part B-Treatment Period 1: Change in the Six-minute Walk Test (6MWT)
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.
Time frame: Baseline to Week 24
Part B-Treatment Period 1: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP)
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.
Time frame: Baseline to Week 24
Part B-Treatment Period 1: Change in World Health Organization (WHO) functional class (FC)
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
Time frame: Baseline to Week 24
Part B-Treatment Period 2: Change in the Six-minute Walk Test (6MWT)
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.
Time frame: Baseline to Month 18
Part B-Treatment Period 2: Change in World Health Organization (WHO) functional class (FC)
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
Time frame: Baseline to Month 18