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

Primary Purpose

Healthy Volunteers

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Inhaled BGF (PT010) Dose 1

Inhaled BGF (PT010) Dose 2

Inhaled BGF (PT010) Dose 3

Inhaled GFF (PT003)

Inhaled Symbicort Dose 1

Inhaled Symbicort Dose 2

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Pearl Therapeutics Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

BGF MDI (PT010) Dose 1

BGF MDI (PT010) Dose 2

BGF MDI (PT010) Dose 3

GFF MDI (PT003)

Symbicort MDI Dose 1

Symbicort MDI Dose 2

Arm Description

BGF MDI Dose 1 taken as 2 inhalations

BGF MDI Dose 2 taken as 2 inhalations

BGF MDI Dose 3 taken as 2 inhalations

GFF MDI (PT003) taken as 2 inhalations

Symbicort MDI taken as 2 inhalations

Symbicort MDI Dose 2 taken as 2 inhalations

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

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.

Full Information

NCT ID

NCT01980615

First Posted

October 21, 2013

Last Updated

April 11, 2014

Sponsor

Pearl Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01980615

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pearl Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BGF MDI (PT010) Dose 1

Arm Type

Experimental

Arm Description

BGF MDI Dose 1 taken as 2 inhalations

Arm Title

BGF MDI (PT010) Dose 2

Arm Type

Experimental

Arm Description

BGF MDI Dose 2 taken as 2 inhalations

Arm Title

BGF MDI (PT010) Dose 3

Arm Type

Experimental

Arm Description

BGF MDI Dose 3 taken as 2 inhalations

Arm Title

GFF MDI (PT003)

Arm Type

Active Comparator

Arm Description

GFF MDI (PT003) taken as 2 inhalations

Arm Title

Symbicort MDI Dose 1

Arm Type

Active Comparator

Arm Description

Symbicort MDI taken as 2 inhalations

Arm Title

Symbicort MDI Dose 2

Arm Type

Active Comparator

Arm Description

Symbicort MDI Dose 2 taken as 2 inhalations

Intervention Type

Drug

Intervention Name(s)

Inhaled BGF (PT010) Dose 1

Intervention Type

Drug

Intervention Name(s)

Inhaled BGF (PT010) Dose 2

Intervention Type

Drug

Intervention Name(s)

Inhaled BGF (PT010) Dose 3

Intervention Type

Drug

Intervention Name(s)

Inhaled GFF (PT003)

Intervention Type

Drug

Intervention Name(s)

Inhaled Symbicort Dose 1

Intervention Type

Drug

Intervention Name(s)

Inhaled Symbicort Dose 2

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 hours following study drug administration

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 hours following study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colin Reisner, MD

Organizational Affiliation

Pearl Therapeutics, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Pearl Therapeutics Study Site

City

Baltimore

State/Province

Maryland

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33152467

Citation

Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.

Results Reference

derived

PubMed Identifier

29544728

Citation

Darken P, DePetrillo P, Reisner C, St Rose E, Dorinsky P. The pharmacokinetics of three doses of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler compared with active controls: A Phase I randomized, single-dose, crossover study in healthy adults. Pulm Pharmacol Ther. 2018 Jun;50:11-18. doi: 10.1016/j.pupt.2018.03.001. Epub 2018 Mar 13.

Results Reference

derived

Learn more about this trial

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

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