Status:
COMPLETED
Randomized, Crossover Safety and Pharmacokinetics Study of PT010
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
COPD
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.
Detailed Description
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of ...
Eligibility Criteria
Inclusion
- Informed Consent Form (ICF) prior to any study related procedures
- Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive
- Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, 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 :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02197975
Start Date
August 1 2014
End Date
October 1 2014
Last Update
October 28 2014
Active Locations (1)
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1
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201