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Open-label Study of Inhaled RVT-1601 in Preterm Infants

Sponsor
Respivant Sciences GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT04007120
Collaborator
Respivant Sciences Inc. (Industry)
8
Enrollment
1
Location
2
Arms
7.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term. In the short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia (BPD), the second most common chronic pediatric respiratory disease after asthma. In the long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital, preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor visits, and hospitalizations for respiratory infections) and resource use, which in turn predisposes infants to the development of lung diseases in childhood and adulthood, including airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There is a significant unmet need for safe and efficacious approaches in the prevention and treatment of respiratory morbidities of prematurity.

The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face mask.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Open-label Study to Assess the Safety, Tolerability, Feasibility, and Pharmacokinetics of Inhaled RVT-1601 in Preterm Infants at High-risk for Long-term Respiratory Morbidities
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
May 29, 2020
Actual Study Completion Date :
May 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: RVT-1601 Low Dose

Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer

Drug: RVT-1601
Inhaled RVT-1601 administered once daily over two days
Experimental: RVT-1601 Mid Dose

Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer

Drug: RVT-1601
Inhaled RVT-1601 administered once daily over two days

Outcome Measures

Primary Outcome Measures

  1. Change in heart rate [Pre-dose and 15 minutes post-dose]

    Assessment of heart rate (beats/min)

  2. Change in blood pressure [Pre-dose and 15 minutes post-dose]

    Assessment of systolic and diastolic blood pressure (mmHg)

  3. Change in oxygenation [Pre-dose and 15 minutes post-dose]

    Assessment of peripheral capillary oxygen saturation (SpO2)

Secondary Outcome Measures

  1. Peak plasma concentration (Cmax) [30 minutes post-dose]

    Assessment of peak plasma concentration of RVT-1601

  2. Total urine excretion [8 hours post-dose]

    Assessment of total urine content of RVT-1601

Eligibility Criteria

Criteria

Ages Eligible for Study:
32 Months to 35 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Preterm infants between 32 weeks 0 days and 34 weeks 6 days of PMA

  • Born between 24 weeks 0 days and 29 weeks 6 days of estimated GA

  • Requiring minimal or no respiratory support (i.e., supplemental oxygen with <2 liters per minute of nasal cannula flow acceptable)

  • Body weight appropriate for gestational age

  • Written informed consent obtained from at least one of the parents or legal guardians

Exclusion Criteria:

  • Requiring invasive or noninvasive respiratory support (e.g., mechanical ventilation, CPAP)

  • Clinically unstable (i.e. unable to maintain SpO2 between 90-95 % , escalating respiratory support in the past 24 hours)

  • Major congenital anomaly (chromosomal, renal, cardiac, hepatic, neurologic or pulmonary malformations)

  • Significant cardiac disorder (i.e., pulmonary hypertension)

  • History of major surgical procedure

  • Any condition that would preclude receiving study drug or performing any study-related procedures

  • Participation in any other investigational drug study

  • History of hypersensitivity or intolerance to cromolyn sodium

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sharp Mary Birch Hospital for Women & Newborns San Diego California United States 92123

Sponsors and Collaborators

  • Respivant Sciences GmbH
  • Respivant Sciences Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Respivant Sciences GmbH
ClinicalTrials.gov Identifier:
NCT04007120
Other Study ID Numbers:
  • RVT1601-RMP-01
First Posted:
Jul 5, 2019
Last Update Posted:
Jun 4, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Jun 4, 2020