Randomized, Crossover Safety and Pharmacokinetics Study of PT010

Completed · Phase 1 · Has a placebo group

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT02197975

Run by

Pearl Therapeutics, Inc.

People needed

20

Starts

2014-08-01

Expected to finish

2014-10-01

Last updated by the study team

2014-10-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SNBL Clinical Pharmacology Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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