Randomized, Crossover Safety and Pharmacokinetics Study of PT010



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 55
Updated:11/8/2014
Start Date:August 2014
End Date:December 2014
Contact:Jane Fitzpatrick
Email:jfitzpatrick@pearltherapeutics.com
Phone:097-975-0333

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A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the 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

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.

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 Japanese descent. Safety and PK will be assessed following a single dose
and during twice-daily (BID) chronic dosing for 7 days.

Inclusion Criteria:

- 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 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
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