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

April 11, 2014 updated by: Pearl Therapeutics, Inc.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States
        • Pearl Therapeutics Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

12 hours following study drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

12 hours following study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Inhaled BGF (PT010) Dose 2

3
Subscribe