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

NCT02566252 | Completed Phase 1

• 1 other identifier: PUL-042-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety; tolerability

Outcome Measures

Primary Outcomes (1)

• 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)

  6 weeks

Other Outcomes (3)

• Effect of pre-treatment with cromolyn sodium or albuterol sulfate on serial forced expiratory volume in 1 second (FEV1) from 0-8 hours post PUL-042 administration

  8 hours

• Number of participants with FEV1 decrease of > 12% compared to pred-dose baseline

  2 weeks

• Number of participants with absolute neutrophil count (ANC) outside the normal range

  2 weeks

Study Arms (3)

PUL-042

EXPERIMENTAL

PUL-042 Inhalation Solution

Drug: PUL-042 Inhalation Solution

Cromolyn sodium

EXPERIMENTAL

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

Drug: PUL-042 Inhalation Solution; Drug: Cromolyn Sodium

Albuterol sulfate

EXPERIMENTAL

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

Drug: PUL-042 Inhalation Solution; Drug: Albuterol sulfate

Interventions

PUL-042 Inhalation Solution DRUG

PUL-042

Albuterol sulfate; Cromolyn sodium; PUL-042

Cromolyn Sodium DRUG

Pre-treatment

Cromolyn sodium

Albuterol sulfate DRUG

Pre-treatment

Albuterol sulfate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pulmotect, Inc.: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

Cromolyn Sodium; Albuterol

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Michelle Ababa, MD

  West Coast Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 2, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

US (1)