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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled BGF (PT010) Dose 1; Drug: Inhaled BGF (PT010) Dose 3; Drug: Inhaled GFF (PT003); Drug: Inhaled Symbicort Dose 1; Drug: Inhaled Symbicort Dose 2

• Registration Number: NCT01980615
• Lead Sponsor: Pearl Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-21
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Symbicort MDI Dose 2	Inhaled Symbicort Dose 1	Symbicort MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 1	Inhaled BGF (PT010) Dose 3	BGF MDI Dose 1 taken as 2 inhalations
BGF MDI (PT010) Dose 1	Inhaled BGF (PT010) Dose 2	BGF MDI Dose 1 taken as 2 inhalations
GFF MDI (PT003)	Inhaled Symbicort Dose 2	GFF MDI (PT003) taken as 2 inhalations
BGF MDI (PT010) Dose 1	Inhaled Symbicort Dose 1	BGF MDI Dose 1 taken as 2 inhalations
BGF MDI (PT010) Dose 1	Inhaled Symbicort Dose 2	BGF MDI Dose 1 taken as 2 inhalations
BGF MDI (PT010) Dose 2	Inhaled BGF (PT010) Dose 3	BGF MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 2	Inhaled Symbicort Dose 2	BGF MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 3	Inhaled BGF (PT010) Dose 1	BGF MDI Dose 3 taken as 2 inhalations
BGF MDI (PT010) Dose 1	Inhaled GFF (PT003)	BGF MDI Dose 1 taken as 2 inhalations
Symbicort MDI Dose 2	Inhaled GFF (PT003)	Symbicort MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 2	Inhaled BGF (PT010) Dose 1	BGF MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 2	Inhaled GFF (PT003)	BGF MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 2	Inhaled Symbicort Dose 1	BGF MDI Dose 2 taken as 2 inhalations
BGF MDI (PT010) Dose 3	Inhaled GFF (PT003)	BGF MDI Dose 3 taken as 2 inhalations
BGF MDI (PT010) Dose 3	Inhaled Symbicort Dose 2	BGF MDI Dose 3 taken as 2 inhalations
BGF MDI (PT010) Dose 3	Inhaled BGF (PT010) Dose 2	BGF MDI Dose 3 taken as 2 inhalations
BGF MDI (PT010) Dose 3	Inhaled Symbicort Dose 1	BGF MDI Dose 3 taken as 2 inhalations
GFF MDI (PT003)	Inhaled BGF (PT010) Dose 1	GFF MDI (PT003) taken as 2 inhalations
GFF MDI (PT003)	Inhaled BGF (PT010) Dose 2	GFF MDI (PT003) taken as 2 inhalations
GFF MDI (PT003)	Inhaled BGF (PT010) Dose 3	GFF MDI (PT003) taken as 2 inhalations
GFF MDI (PT003)	Inhaled Symbicort Dose 1	GFF MDI (PT003) taken as 2 inhalations
Symbicort MDI Dose 1	Inhaled BGF (PT010) Dose 1	Symbicort MDI taken as 2 inhalations
Symbicort MDI Dose 1	Inhaled BGF (PT010) Dose 2	Symbicort MDI taken as 2 inhalations
Symbicort MDI Dose 1	Inhaled BGF (PT010) Dose 3	Symbicort MDI taken as 2 inhalations
Symbicort MDI Dose 1	Inhaled GFF (PT003)	Symbicort MDI taken as 2 inhalations
Symbicort MDI Dose 1	Inhaled Symbicort Dose 2	Symbicort MDI taken as 2 inhalations
Symbicort MDI Dose 2	Inhaled BGF (PT010) Dose 1	Symbicort MDI Dose 2 taken as 2 inhalations
Symbicort MDI Dose 2	Inhaled BGF (PT010) Dose 2	Symbicort MDI Dose 2 taken as 2 inhalations
Symbicort MDI Dose 2	Inhaled BGF (PT010) Dose 3	Symbicort MDI Dose 2 taken as 2 inhalations

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pearl Therapeutics Study Site; 🇺🇸 Baltimore, Maryland, United States