PK Study of PT003 and PT001 in Japanese Healthy Subjects
Completed · Phase 1
Conditions studied: COPD
In brief
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.
Key facts
- Study ID
- NCT02196714
- Run by
- Pearl Therapeutics, Inc.
- People needed
- 24
- Starts
- 2014-07-01
- Last updated by the study team
- 2017-04-26
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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 — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.