a randomized, open-label, single-dose, single-center, crossover study in healthy subjects to assess the relative bioavailability of pt010

Conditions: Chronic Obstructive Pulmonary Disease

Summary: randomized, open-label, single-dose, single-center, crossover study in healthy subjects to assess the relative bioavailability of pt010

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 oral charcoal

Eligibility 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)

Keywords: copd