Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)

Overview

This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.

Full Title of Study: “A Randomized, Open-label, Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects and the Effect of Pretreatment With Cromolyn Sodium or Albuterol Sulfate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Detailed Description

Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week washout period and then be assigned to the alternative treatment (i.e., subjects who received cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then followed for an additional 2 weeks.

Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.

Interventions

  • Drug: PUL-042 Inhalation Solution
    • PUL-042
  • Drug: Cromolyn Sodium
    • Pre-treatment
  • Drug: Albuterol sulfate
    • Pre-treatment

Arms, Groups and Cohorts

  • Experimental: PUL-042
    • PUL-042 Inhalation Solution
  • Experimental: Cromolyn sodium
    • Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration
  • Experimental: Albuterol sulfate
    • Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
    • Time Frame: 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Males or females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo oophorectomy or post- menopausal for > 2 years) with a negative urine human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit
  • Body Mass Index (BMI) between 18 and 30 kg/m2
  • Ability to perform spirometry according to American Thoracic Society standards
  • Normal spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC] ≥ 80% and ≤ 120% based on predicted values) at the Screening Visit and at Visit 2.
  • Pulse oximetry ≥95% on room air
  • Ability to understand and give informed consent
  • Males willing to practice contraception (condom + spermicide) during the study and for 30 days after completion of the

Exclusion Criteria

  • Febrile (temperature ≥ 99.5°Fahrenheit)
  • A history of use of any tobacco products during the year prior to the Screening Visit and a total exposure of > 5 pack years or a positive urine cotinine level at the Screening Visit
  • Clinically significant laboratory finding as determined by the Principal Investigator or designee at the Screening Visit or at Visit 2
  • Positive test for drugs of abuse (alcohol, cannabinoids, opiates, cocaine, amphetamine, barbiturates, benzodiazepine, phencyclidine)
  • Any active medical problems requiring treatment
  • Subjects who exhibit symptoms of respiratory infection or have experienced respiratory symptoms of an upper respiratory infection within 30 days prior to the Screening Visit.
  • History of chronic pulmonary disease (eg, asthma [including atopic asthma, exercise induced asthma, or asthma triggered by respiratory infection], pulmonary fibrosis), pulmonary hypertension, or heart failure
  • Any out of range QTc Fridericia (QTcF) or other clinically significant ECG findings as determined by the Principal Investigator or designee at Visit 2 or Visit 12.
  • History of atopic reactions
  • Administration of any anti-inflammatory therapy (eg, no steroidal anti-inflammatory drugs or corticosteroids) within 4 weeks prior to randomization or expected to be ongoing during the study
  • An anticipated need for use of any inhaled medication during the study
  • Intake of coffee, tea, cola drinks, chocolate on days of Study Visits 1-21
  • Intake of alcohol, caffeine or strenuous exercise within 72 hours prior to study drug administration or intake of grapefruit within 7 days prior to the administration of study drug
  • Intake of alcohol within 4 hours of spirometry; smoking within 1 hour of spirometry; performing vigorous exercise within 30 minutes of spirometry; wearing clothing that substantially restricts full chest and abdominal expansion; or eating a large meal within 2 hours of spirometry
  • Administration of any over the counter (OTC)/prescription medication, supplements, herbals or vitamins within 14 days prior to study drug administration. Administration of Tylenol within 72 hours of study drug administration (doses up to 2g/day will be allowed prior to 72 hours before study drug administration)
  • Exposure to any investigational agent within 30 days prior to the Screening Visit
  • Receipt of a flu vaccine in the last 3 months
  • Prior exposure to PUL-042
  • Known positive for human immunodeficiency virus, or on active anti-retroviral therapy and known hepatitis B surface antigen positive or hepatitis C positive

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pulmotect, Inc.
  • Collaborator
    • WCCT Global
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michelle Ababa, MD, Principal Investigator, West Coast Clinical Trials

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