PK Study of PT003 and PT001 in Japanese Healthy Subjects
This trial is active, not recruiting.
|Treatments||glycopyrronium and formoterol fumarate (gff) dose 1, glycopyrronium and formoterol fumarate (gff) dose 2, glycopyrronium (gp) dose 1, glycopyrronium (gp) dose 2|
|Sponsor||Pearl Therapeutics, Inc.|
|Start date||July 2014|
|End date||September 2014|
|Trial size||24 participants|
|Trial identifier||NCT02196714, PT003010-00|
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
|Endpoint classification||pharmacokinetics study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator)|
Overall Pharmacokinetic profile of PT003 and PT001
time frame: 24 hour post dose
Overall Safety of PT003 and PT001
time frame: 24 hours post dose
Male or female participants from 18 years up to 45 years old.
Inclusion Criteria: Informed Consent Form (ICF) prior to any study related procedures - Male and female first generation Japanese subjects 18 to 45 years, inclusive - Good general health - Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential - Clinical labs within normal ranges or determined to be not clinically significant by the Investigator Exclusion Criteria: - Pregnancy, nursing female subjects, or subjects trying to conceive - Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study - History of ECG abnormalities - Cancer not in complete remission for at least 5 years - Clinically significant, symptomatic prostatic hypertrophy - Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening - Clinically significant bladder neck obstruction or urinary retention - Inadequately treated glaucoma - History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study - Subjects with pre-existing anemia and/or iron deficiency
|Official title||A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects|
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