- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980615
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States
- Pearl Therapeutics Study Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
|
|
Experimental: BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
|
|
Experimental: BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
|
|
Active Comparator: GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
|
|
Active Comparator: Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
|
|
Active Comparator: Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
|
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT010001-00
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.
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