Status:
COMPLETED
PK Study of PT003 and PT001 in Japanese Healthy Subjects
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
COPD
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02196714
Start Date
July 1 2014
Last Update
April 26 2017
Active Locations (1)
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1
SNBL
Baltimore, Maryland, United States, 21201