Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2014

Interventions

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

Arms, Groups and Cohorts

  • Experimental: PT010
    • PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
  • Experimental: PT009
    • PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
  • Active Comparator: Symbicort Turbohaler
    • Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations

Clinical Trial Outcome Measures

Primary Measures

  • Overall Safety of PT010, PT009 and Symbicort Turbohaler
    • Time Frame: 12 hours post dose
    • 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

Secondary Measures

  • ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose
  • ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler
    • Time Frame: 12 Hour post dose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pearl Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chadwick Orevillo, Study Chair, Pearl Therapeutics

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