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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2016
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.
- Drug: PUL-042 Inhalation Solution
- Drug: Cromolyn Sodium
- Drug: Albuterol sulfate
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
- 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
- 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
- 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
- Lead Sponsor
- Pulmotect, Inc.
- WCCT Global
- Provider of Information About this Clinical Study
- Overall Official(s)
- Michelle Ababa, MD, Principal Investigator, West Coast Clinical Trials
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