PK Study of PT003 and PT001 in Japanese Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/8/2014 |
| Start Date: | July 2014 |
| Contact: | Jane Fitzpatrick |
| Email: | jfitzpatrick@pearltherapeutics.com |
| Phone: | 973-975-0333 |
A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,
Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the
Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the
Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
Inclusion Criteria:
Informed Consent Form (ICF) prior to any study related procedures
- Male and female first generation Japanese subjects 18 to 45 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
We found this trial at
1
site
