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Completed

NCT Number: NCT01980615

Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers

This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to budesonide following administration of Symbicort MDI.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pearl Therapeutics Study Site

Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provide signed written informed consent form
  • 18 and 45 years (inclusive)
  • Healthy subject confirmed by a thorough medical history and physical examination, ECG, vital signs and clinical laboratory tests
  • Females of childbearing potential and males with female partners of childbearing potential must agree to use medically acceptable contraception
  • Body mass index (BMI) between 18.5 and 32 kg/m2 (inclusive) and a minimum weight of 50 kg at the screening visit
  • Results of complete laboratory analyses should be within the normal range or determined to be not clinically significant by the Investigator

Exclusion criteria

  • Pregnancy, nursing female subjects, or subjects trying to conceive
  • Clinically significant medical conditions
  • History of ECG abnormalities
  • Symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
  • Known diagnosis of glaucoma
  • Known or suspected history of substance-related disorders within 1 year of screening
  • Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening period
  • Hypersensitivity to lactose or any drug or component of the formulation(s) used in this study
  • Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at screening.
  • Major surgery within four weeks or minor surgery within 2 weeks of drug administration
  • Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for study participation

Treatment and study plan

Inhaled BGF (PT010) Dose 1

Drug

Inhaled BGF (PT010) Dose 2

Drug

Inhaled BGF (PT010) Dose 3

Drug

Inhaled GFF (PT003)

Drug

Inhaled Symbicort Dose 1

Drug

Inhaled Symbicort Dose 2

Drug

Primary outcomes

  1. Overall safety of BGF, GFF, and Symbicort MDI based on the group of outcome measures for safety.

    Time frame: 12 hours following study drug administration

    Safety of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort Inhalation Aerosol.

    The safety of BGF MDI, Symbicort MDI and GFF MDI will be assessed from physical examination findings, adverse event (AE) reporting including SAE reporting, vital signs (blood pressure, heart rate, respiratory rate and body temperature), clinical laboratory values (hematology, biochemistry, and urinalysis), and findings from 12-lead safety electrocardiograms (ECGs).

Secondary outcomes

  1. Overall pharmacokinetic profile of BGF, GFF, and Symbicort MDI based on the group of outcome measures for pharmacokinetics.

    Time frame: 12 hours following study drug administration

    Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), Symbicort MDI and GFF MDI.

    The PK of BGF MDI, Symbicort MDI and GFF MDI will be assessed and compared from plasma concentrations of each drug.

    PK parameters at all doses will include Cmax, tmax, t½, AUC0-12, AUC0-t, CL/F, Vd/F, and λz. Other PK parameters may be calculated, as appropriate.

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2013
Registry last updated
Apr 14, 2014

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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