A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

• Status: Completed
• Trial end date: 2017-12-15
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Charcoal

Criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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)