Status:
COMPLETED
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Detailed Description
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without O...
Eligibility Criteria
Inclusion
- Key
- Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
- Male and female subjects 18 to 40 years of age, inclusive
- Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
- Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
- Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period
- Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.
- Demonstrate correct MDI administration technique
- Key
Exclusion
- For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
- Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- Subjects who have cancer that has not been in complete remission for at least 5 years
- Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
- Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
- History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening
- History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting
- A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period
- Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period
- Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03311373
Start Date
October 17 2017
End Date
December 15 2017
Last Update
June 11 2020
Active Locations (1)
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1
Pearl Investigative Site
Baltimore, Maryland, United States, 21201