Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Glycopyrrolate

Criteria

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