Summary

for people ages 18-75 (full criteria)
at Sacramento, California and other locations
study started
estimated completion
Mark Avdalovic, MD

Description

Summary

This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension (PAH).

Official Title

A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension

Details

This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension (PAH).

Study participation for each patient will last approximately 3 months and will consist of a screening period (up to 28 days in duration), a baseline period (day 1, pre-dose), a 6-week treatment period, and a 2-week follow-up period.

The study will enroll approximately 36 patients at approximately 20 centers across the United States and Canada.

Keywords

Pulmonary Arterial Hypertension Pulmonary arterial hypertension (PAH) Pulmonary hypertension (PH) RVT-1201 Rodatristat ethyl Tryptophan hydroxylase (TPH) Serotonin reduction ELEVATE 1 KAR5417 Familial Primary Pulmonary Hypertension Hypertension

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  • Symptomatic PAH belonging to one of the following types:
  • Idiopathic
  • Heritable
  • Drug- or toxin- induced
  • Associated with one of the following: connective tissue disease or congenital heart disease
  • World Health Organization (WHO) Functional Class (FC) II or III
  • PAH diagnosed by right heart cardiac catheterization prior to Screening
  • Receiving standard of care treatment for PAH with oral monotherapy or dual therapy for at least 12 weeks prior to Screening at a dose which has been stable for at least 8 weeks prior to Screening
  • If on a diuretic, dose must be stable for at least 4 weeks prior to Screening, with no changes anticipated during study participation
  • 6-Minute Walk Distance (6MWD) between 150 and 500 meters at Screening and Baseline visits
  • Plasma N-terminal pro B-type natriuretic peptide (NT-proBNP) level ≥ 300 pg/mL at Screening
  • Ability and willingness to give written informed consent and to comply with the requirements of the study

Key Exclusion Criteria:

  • PAH associated with human immunodeficiency virus (HIV) infection, portal hypertension or schistosomiasis
  • Other types of pulmonary hypertension (PH):
  • Pulmonary hypertension due to left heart disease (WHO PH Group 2)
  • Pulmonary hypertension due to lung diseases and/or hypoxia (WHO PH Group 3)
  • Chronic thromboembolic pulmonary hypertension (WHO PH Group 4)
  • Pulmonary hypertension with unclear multifactorial mechanisms (WHO PH Group 5)
  • Hospitalization for pulmonary hypertension within 12 weeks of screening
  • Cardiopulmonary rehabilitation program based on exercise (planned, or started ≤ 12 weeks prior to Screening)
  • Prostanoid or prostacyclin receptor agonist therapy within 12 weeks of screening
  • Evidence of left-sided heart disease
  • If Pulmonary function tests were done prior to screening, Pulmonary function tests demonstrate obstructive or restrictive lung disease
  • Use of telotristat (Xermelo®) within the last 6 months
  • Use of any investigational drug within 30 days or five half-lives (whichever is longer) prior to Screening, or 90 days if an investigational drug for PAH
  • Have uncontrolled atrial fibrillation (AFib) or other uncontrolled arrhythmias
  • Body mass index (BMI) >45 kg/m2
  • Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception

Locations

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • SBPA Research LLC accepting new patients
    Santa Barbara California 93105 United States

Lead Scientist

  • Mark Avdalovic, MD
    Professor, Pulmonary, Critical Care, and Sleep Medicine. Authored (or co-authored) 30 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Altavant Sciences GmbH
Links
RVT-1201-2001 (ELEVATE 1) study website
Sign up for this study
ID
NCT03924154
Phase
Phase 2
Study Type
Interventional
Last Updated