A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

Novartis

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Healthy Volunteers, Pulmonary Arterial Hypertension

Treatments: Drug: Placebo; Drug: LTP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06649110

CLTP001A12202

Details and patient eligibility

About

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Full 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.

Enrollment: 232 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria may apply.
• For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 4 patient groups, including a placebo group

LTP001 Dose 1

Experimental group

Treatment:

Drug: LTP

LTP001 Dose 2

Experimental group

Treatment:

Drug: LTP

LTP001 Dose 3

Experimental group

Treatment:

Drug: LTP

Placebo

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: Placebo