Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/15/2018 |
| Start Date: | June 1, 2014 |
| End Date: | September 1, 2014 |
A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects
This is a single-center, Phase I, healthy adult subject study with a randomized, double
blind, three period, three-treatment, cross-over design.
blind, three period, three-treatment, cross-over design.
Inclusion Criteria:
- Informed Consent Form (ICF) prior to any study related procedures
- Male and female subjects 18 to 55 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 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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