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

NCT ID: NCT02566252

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PUL-042

PUL-042 Inhalation Solution

Group Type: EXPERIMENTAL

PUL-042 Inhalation Solution

Intervention Type: DRUG

PUL-042

Cromolyn sodium

Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration

Group Type: EXPERIMENTAL

PUL-042 Inhalation Solution

Intervention Type: DRUG

PUL-042

Cromolyn Sodium

Intervention Type: DRUG

Pre-treatment

Albuterol sulfate

Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration

Group Type: EXPERIMENTAL

PUL-042 Inhalation Solution

Intervention Type: DRUG

PUL-042

Albuterol sulfate

Intervention Type: DRUG

Pre-treatment

Interventions

PUL-042 Inhalation Solution

PUL-042

Intervention Type: DRUG

Cromolyn Sodium

Pre-treatment

Intervention Type: DRUG

Albuterol sulfate

Pre-treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

WCCT Global

INDUSTRY

Sponsor Role: collaborator

Pulmotect, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Ababa, MD

Role: PRINCIPAL_INVESTIGATOR

West Coast Clinical Trials

Locations

WCCT Global

Cypress, California, United States

Countries

United States

Other Identifiers

PUL-042-003

Identifier Type: -

Identifier Source: org_study_id