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Completed

NCT Number: NCT02189304

Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PT010

Drug

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

Other names: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol

PT009

Drug

PT009 administered as 2 inhalations

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

Symbicort Turbohaler

Drug

Symbicort Turbohaler taken as 2 inhalations

Other names: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder

Primary outcomes

  1. 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 outcomes

  1. ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  2. ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  3. ◦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

  4. ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  5. ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  6. ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  7. ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  8. ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler

    Time frame: 12 Hour post dose

  9. ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler

    Time frame: 12 Hour post dose

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2014
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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