Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

COPD Clinical Trial

Official title:

A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189304
• Other study ID #: PT010002-00
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2014
• Est. completion date: September 1, 2014

Study information

• Verified date: June 2018
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 1, 2014
• Est. primary completion date: September 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
• PT009
PT009 administered as 2 inhalations
• Symbicort Turbohaler
Symbicort Turbohaler taken as 2 inhalations

Locations

Country	Name	City	State
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Safety of PT010, PT009 and Symbicort Turbohaler	The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram	12 hours post dose
Secondary	?Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler		12 Hour post dose
Secondary	?Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler		12 Hour post dose
Secondary	?Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler		12 Hour post dose
Secondary	?Area under the curve from 0 extrapolated to infinity (AUC0-8) of PT010, PT009, and Symbicort Turbohaler		12 Hour post dose
Secondary	?Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler		12 Hour post dose
Secondary	?Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler		12 Hour post dose
Secondary	?Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler		12 Hour post dose
Secondary	?Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler		12 Hour post dose
Secondary	?Termination elimination rate constant (?z) of PT010, PT009, and Symbicort Turbohaler		12 Hour post dose