Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

Completed · Phase 1

Conditions studied: COPD

In brief

This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.

Key facts

Study ID: NCT02189304
Run by: Pearl Therapeutics, Inc.
People needed: 59
Starts: 2014-06-01
Expected to finish: 2014-09-01
Last updated by the study team: 2018-06-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

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 Clinical Pharmacology Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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