Part A: Healthy volunteers (Part A is not applicable to the EU; for information only) Part B: pulmonary arterial hypertension
Conditions
Brief summary
Part A: All safety endpoints, including vital signs, ECG, central lab evaluations and AEs up to and including the EoS visit. Part B: (Period 1) Change in PVR from baseline to 24 weeks (Period 2): All safety endpoints, including vital signs, ECG, central lab evaluations, treatment-emergent AEs and discontinuations due to AEs.
Detailed description
Part A: Cmax, Tmax, AUClast, AUCinf and T1/2 of LTP001 Part B: (Period 1) Change in 6MWD from baseline to 24 weeks. (Period 2) Change in 6MWD from baseline to 18 months, Part B Period 2: Number of participants experiencing an improvement in WHO FC from baseline to 18 months, Part B (Period 1): Change in WHO FC from baseline to 24 weeks, Part B (Period 1): All safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: All safety endpoints, including vital signs, ECG, central lab evaluations and AEs up to and including the EoS visit. Part B: (Period 1) Change in PVR from baseline to 24 weeks (Period 2): All safety endpoints, including vital signs, ECG, central lab evaluations, treatment-emergent AEs and discontinuations due to AEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Cmax, Tmax, AUClast, AUCinf and T1/2 of LTP001 Part B: (Period 1) Change in 6MWD from baseline to 24 weeks. (Period 2) Change in 6MWD from baseline to 18 months, Part B Period 2: Number of participants experiencing an improvement in WHO FC from baseline to 18 months, Part B (Period 1): Change in WHO FC from baseline to 24 weeks, Part B (Period 1): All safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events | — |
Countries
Belgium, Czechia, France, Germany, Greece, Italy, Latvia, Poland, Portugal, Romania, Spain