A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Key facts
- Where
- Angers, Brest, Grenoble Cedex 9, Le Kremlin-Bicetre, Montpellier Cedex 5, Nice, Pessac, Poitiers, Saint-Priest-en-Jarez, Strasbourg Cedex, Toulouse és Vandoeuvre Les Nancy, FranciaországSee the 12 sites
- Phase
- 1/2. fázis
Where in Franciaország
- Centre Hospitalier Universitaire D'AngersAngers, FranciaországTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranciaországTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranciaországTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranciaországTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranciaországTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2024-513613-12-00
- Record updated
- 2026. november 10.
- Original description
Part A: To assess the safety and tolerability of single and multiple doses of LTP001 in healthy participants Part B: Period 1: To characterize the dose-response relationship of LTP001 plus standard-of-care (SoC) compared to placebo plus SoC in participants with WHO functional class (FC) II-III PAH Period 2: To assess the safety and tolerability of LTP001Read full original descriptionShow less
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of LTP001 in healthy adult participants (Part A) and to evaluate the efficacy and safety of LTP001 for the treatment of participants with pulmonary arterial hypertension (Part B)
Part A: To assess the safety and tolerability of single and multiple doses of LTP001 in healthy participants Part B: Period 1: To characterize the dose-response relationship of LTP001 plus standard-of-care (SoC) compared to placebo plus SoC in participants with WHO functional class (FC) II-III PAH Period 2: To assess the safety and tolerability of LTP001
Inclusion: Part A: Signed informed consent must be obtained prior to participation in the study. Part B: Confirmed diagnosis of pulmonary arterial hypertension; Part A: Healthy male and non-childbearing potential female participants Part B: Pre-randomization PVR ≥400 dyn.sec.cm; Part A: In good health in the opinion of the investigator and as determined by medical history, physical examination, vital signs, ECG, and laboratory tests. Part B: Treatment with stable doses of standard-of-care PAH therapies; Part A: Able to read, speak, and understand the local language, to understand and comply with the requirements of the study. Part B: 6MWD ≥ 150 m and ≤550 m.
Exclusion: Part A: Use of any investigational drugs within 5 half-lives or within 30 days or until the expected pharmacodynamic effect has returned to baseline prior to initial dosing, whichever is longer. Part B: Women of child-bearing potential unless they are using highly effective methods of contraception; Part A: History or current diagnosis of clinically significant ECG or cardiac abnormalities indicating significant risk of safety for participants. Part B: Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study; Part A: History of hypersensitivity to the investigational compound/compound class or excipients being used in this study. Part B: Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment; Part B: History of hypersensitivity to any of the study treatments or excipients.