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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1)

Clinicaltrials.gov identifier NCT03924154

Recruitment Status Terminated (Inability to enroll)

First Posted April 23, 2019

Last update posted March 9, 2020

Study Description

Brief 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).

  • Condition or Disease:Pulmonary Arterial Hypertension
  • Intervention/Treatment: Drug: RVT-1201
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 3 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Following screening assessments, PAH patients who meet all entrance criteria will be randomly assigned to receive one of the following treatments in a ratio of 2:1: Arm 1 (n=24) - RVT-1201 Treatment: RVT-1201 immediate-release tablets will be administered orally, at a dose of 600 mg twice daily (BID), for a total of 6 weeks in addition to the patient's current standard of care (SOC) medication(s) for PAH. Arm 2 (n=12) - Placebo Treatment: Matching placebo tablets will be administered orally, at a dose of 600 mg twice daily (BID), for a total of 6 weeks in addition to the patient's current SOC medication(s) for PAH. Participants will be followed in face-to-face visits with trial personnel every 2 weeks for 8 weeks (6 weeks of treatment plus a 2-week follow-up), with an additional phone call at Week 1, to assess drug effects and monitor safety during their treatments.
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: August 2019
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Experimental: RVT-1201
RVT-1201 600 mg immediate-release tablet, administered orally twice daily with food for 6 weeks, in addition to the patient's current standard of care medication(s) for PAH (n=24 [Anticipated])
Drug: RVT-1201
RVT-1201 600 mg immediate-release tablet
Placebo Comparator: Placebo
Matching placebo tablet, administered orally twice daily with food for 6 weeks, in addition to the patient's current standard of care medication(s) for PAH (n=12 [Anticipated])
Drug: Placebo
Inactive pill manufactured to mimic RVT-1201 600 mg immediate-release tablet
Outcome Measures
  • Primary Outcome Measures: 1. Adverse events (AEs) and discontinuations due to AEs [ Time Frame: 8 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and discontinuations due to AEs
  • Secondary Outcome Measures: 1. Area under the plasma concentration versus time curve (AUC) of KAR5417 (the active metabolite of RVT-1201) [ Time Frame: 6 weeks ]
    Measured KAR5417 plasma concentrations from sparse sampling will be used to assess the pharmacokinetic (PK) parameter AUC of KAR5417 administered twice daily in patients with PAH, by means of population PK (PopPK) analysis
  • 2. Relationship between KAR5417 exposure and percent change from baseline in plasma concentrations of the serotonin-related biomarkers [ Time Frame: 6 weeks ]
    Evaluate the relationship between exposure (area under the plasma concentration versus time curve [AUC]) of KAR5417 (the active metabolite of RVT-1201) and percent change from baseline in plasma concentrations of the serotonin-related biomarkers (5-HIAA and 5-HT)
  • 3. Concentration of biomarkers of serotonin biosynthesis in plasma [ Time Frame: 8 weeks ]
    Absolute concentrations and percent change from baseline in plasma 5-hydroxyindoleacetic acid (5-HIAA) and plasma 5-hydroxytryptamine (5-HT, also known as serotonin) concentrations
  • 4. Concentration of biomarkers of serotonin biosynthesis in urine [ Time Frame: 8 weeks ]
    Concentration of urine 5-hydroxyindoleacetic acid (5-HIAA) will be normalized against urine creatinine concentration to determine absolute ratio and percent change from baseline in urine 5-HIAA:creatinine ratio
  • 5. Study drug (RVT-1201) and active metabolite (KAR5417) plasma concentrations [ Time Frame: 6 weeks ]
    Measured RVT-1201 and KAR5417 plasma concentrations from sparse sampling
  • 6. Relationship between KAR5417 exposure and percent change from baseline in urine concentrations of the serotonin-related biomarkers [ Time Frame: 6 weeks ]
    Evaluate the relationship between exposure (area under the plasma concentration versus time curve [AUC]) of KAR5417 (the active metabolite of RVT-1201) and percent change from baseline in urine 5-HIAA:creatinine concentration ratio
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations
Show 23 Study Locations
Sponsors and Collaborators

Altavant Sciences GmbH

Altavant Sciences, Inc.

PPD

Investigators

Study Director: Ed Parsley, DO Altavant Sciences

More Information
  • Responsible Party: Altavant Sciences GmbH
  • ClinicalTrials.gov Identifier: NCT03924154 History of Changes
  • Other Study ID Numbers: RVT-1201-2001
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: March 9, 2020
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Altavant Sciences GmbH: Pulmonary arterial hypertension (PAH)
    Pulmonary hypertension (PH)
    RVT-1201
    Rodatristat ethyl
    Tryptophan hydroxylase (TPH)
    Serotonin reduction
    ELEVATE 1
    KAR5417
  • Additional relevant MeSH terms: Hypertension Familial Primary Pulmonary Hypertension