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 |
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.
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.
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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