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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

NCT ID: NCT01980615

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BGF MDI (PT010) Dose 1

BGF MDI Dose 1 taken as 2 inhalations

Group Type EXPERIMENTAL

Inhaled BGF (PT010) Dose 2

Intervention Type DRUG

Inhaled BGF (PT010) Dose 3

Intervention Type DRUG

Inhaled GFF (PT003)

Intervention Type DRUG

Inhaled Symbicort Dose 1

Intervention Type DRUG

Inhaled Symbicort Dose 2

Intervention Type DRUG

BGF MDI (PT010) Dose 2

BGF MDI Dose 2 taken as 2 inhalations

Group Type EXPERIMENTAL

Inhaled BGF (PT010) Dose 1

Intervention Type DRUG

Inhaled BGF (PT010) Dose 3

Intervention Type DRUG

Inhaled GFF (PT003)

Intervention Type DRUG

Inhaled Symbicort Dose 1

Intervention Type DRUG

Inhaled Symbicort Dose 2

Intervention Type DRUG

BGF MDI (PT010) Dose 3

BGF MDI Dose 3 taken as 2 inhalations

Group Type EXPERIMENTAL

Inhaled BGF (PT010) Dose 1

Intervention Type DRUG

Inhaled BGF (PT010) Dose 2

Intervention Type DRUG

Inhaled GFF (PT003)

Intervention Type DRUG

Inhaled Symbicort Dose 1

Intervention Type DRUG

Inhaled Symbicort Dose 2

Intervention Type DRUG

GFF MDI (PT003)

GFF MDI (PT003) taken as 2 inhalations

Group Type ACTIVE_COMPARATOR

Inhaled BGF (PT010) Dose 1

Intervention Type DRUG

Inhaled BGF (PT010) Dose 2

Intervention Type DRUG

Inhaled BGF (PT010) Dose 3

Intervention Type DRUG

Inhaled Symbicort Dose 1

Intervention Type DRUG

Inhaled Symbicort Dose 2

Intervention Type DRUG

Symbicort MDI Dose 1

Symbicort MDI taken as 2 inhalations

Group Type ACTIVE_COMPARATOR

Inhaled BGF (PT010) Dose 1

Intervention Type DRUG

Inhaled BGF (PT010) Dose 2

Intervention Type DRUG

Inhaled BGF (PT010) Dose 3

Intervention Type DRUG

Inhaled GFF (PT003)

Intervention Type DRUG

Inhaled Symbicort Dose 2

Intervention Type DRUG

Symbicort MDI Dose 2

Symbicort MDI Dose 2 taken as 2 inhalations

Group Type ACTIVE_COMPARATOR

Inhaled BGF (PT010) Dose 1

Intervention Type DRUG

Inhaled BGF (PT010) Dose 2

Intervention Type DRUG

Inhaled BGF (PT010) Dose 3

Intervention Type DRUG

Inhaled GFF (PT003)

Intervention Type DRUG

Inhaled Symbicort Dose 1

Intervention Type DRUG

Interventions

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Inhaled BGF (PT010) Dose 1

Intervention Type DRUG

Inhaled BGF (PT010) Dose 2

Intervention Type DRUG

Inhaled BGF (PT010) Dose 3

Intervention Type DRUG

Inhaled GFF (PT003)

Intervention Type DRUG

Inhaled Symbicort Dose 1

Intervention Type DRUG

Inhaled Symbicort Dose 2

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Reisner, MD

Role: STUDY_CHAIR

Pearl Therapeutics, Inc.

Locations

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Pearl Therapeutics Study Site

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33152467 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29544728 (View on PubMed)

Other Identifiers

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PT010001-00

Identifier Type: -

Identifier Source: org_study_id

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