Clinical trial NCT01980615: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall safety of BGF, GFF, and Symbicort MDI based on the group of outcome measures for safety.
timeFrame: 12 hours following study drug administration
Secondary outcomes:
measure: Overall pharmacokinetic profile of BGF, GFF, and Symbicort MDI based on the group of outcome measures for pharmacokinetics.
timeFrame: 12 hours following study drug administration
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pearl Therapeutics Study Site
state: Maryland
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, MD
role: STUDY_CHAIR
References:
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.
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.