Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

Pearl Therapeutics

Status and phase: Completed; Phase 1

Conditions: COPD

Treatments: Drug: PT009; Drug: Symbicort Turbohaler; Drug: PT010

Study type: Interventional

Funder types: Industry

Identifiers

NCT02189304

PT010002-00

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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59 participants in 3 patient groups

PT010

Experimental group

Description:

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Treatment:

Drug: Symbicort Turbohaler

Drug: PT009

PT009

Experimental group

Description:

PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Treatment:

Drug: PT010

Drug: Symbicort Turbohaler

Symbicort Turbohaler

Active Comparator group

Description:

Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations

Treatment:

Drug: PT010

Drug: PT009