Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
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
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Nov 2013
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 14, 2014
April 1, 2014
1 month
October 21, 2013
April 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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).
12 hours following study drug administration
Secondary Outcomes (1)
Overall pharmacokinetic profile of BGF, GFF, and Symbicort MDI based on the group of outcome measures for pharmacokinetics.
12 hours following study drug administration
Study Arms (6)
BGF MDI (PT010) Dose 1
EXPERIMENTALBGF MDI Dose 1 taken as 2 inhalations
BGF MDI (PT010) Dose 2
EXPERIMENTALBGF MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 3
EXPERIMENTALBGF MDI Dose 3 taken as 2 inhalations
GFF MDI (PT003)
ACTIVE COMPARATORGFF MDI (PT003) taken as 2 inhalations
Symbicort MDI Dose 1
ACTIVE COMPARATORSymbicort MDI taken as 2 inhalations
Symbicort MDI Dose 2
ACTIVE COMPARATORSymbicort MDI Dose 2 taken as 2 inhalations
Interventions
Eligibility Criteria
You may qualify if:
- Provide signed written informed consent form
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pearl Therapeutics Study Site
Baltimore, Maryland, United States
Related Publications (2)
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.
PMID: 33152467DERIVEDDarken 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.
PMID: 29544728DERIVED
Study Officials
- STUDY CHAIR
Colin Reisner, MD
Pearl Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2013
First Posted
November 11, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 14, 2014
Record last verified: 2014-04