Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

Launched by PEARL THERAPEUTICS, INC. · Jul 10, 2014

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent Form (ICF) prior to any study related procedures
• • Male and female subjects 18 to 55 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