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

Pearl Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Inhaled GFF (PT003); Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled BGF (PT010) Dose 3; Drug: Inhaled Symbicort Dose 1; Drug: Inhaled BGF (PT010) Dose 1; Drug: Inhaled Symbicort Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01980615

PT010001-00

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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84 participants in 6 patient groups

BGF MDI (PT010) Dose 1

Experimental group

Description:

BGF MDI Dose 1 taken as 2 inhalations

Treatment:

Drug: Inhaled GFF (PT003)

Drug: Inhaled BGF (PT010) Dose 2

Drug: Inhaled Symbicort Dose 2

Drug: Inhaled BGF (PT010) Dose 3

Drug: Inhaled Symbicort Dose 1

BGF MDI (PT010) Dose 2

Experimental group

Description:

BGF MDI Dose 2 taken as 2 inhalations

Treatment:

Drug: Inhaled GFF (PT003)

Drug: Inhaled BGF (PT010) Dose 1

Drug: Inhaled Symbicort Dose 2

Drug: Inhaled BGF (PT010) Dose 3

Drug: Inhaled Symbicort Dose 1

BGF MDI (PT010) Dose 3

Experimental group

Description:

BGF MDI Dose 3 taken as 2 inhalations

Treatment:

Drug: Inhaled GFF (PT003)

Drug: Inhaled BGF (PT010) Dose 2

Drug: Inhaled BGF (PT010) Dose 1

Drug: Inhaled Symbicort Dose 2

Drug: Inhaled Symbicort Dose 1

GFF MDI (PT003)

Active Comparator group

Description:

GFF MDI (PT003) taken as 2 inhalations

Treatment:

Drug: Inhaled BGF (PT010) Dose 2

Drug: Inhaled BGF (PT010) Dose 1

Drug: Inhaled Symbicort Dose 2

Drug: Inhaled BGF (PT010) Dose 3

Drug: Inhaled Symbicort Dose 1

Symbicort MDI Dose 1

Active Comparator group

Description:

Symbicort MDI taken as 2 inhalations

Treatment:

Drug: Inhaled GFF (PT003)

Drug: Inhaled BGF (PT010) Dose 2

Drug: Inhaled BGF (PT010) Dose 1

Drug: Inhaled Symbicort Dose 2

Drug: Inhaled BGF (PT010) Dose 3

Symbicort MDI Dose 2

Active Comparator group

Description:

Symbicort MDI Dose 2 taken as 2 inhalations

Treatment:

Drug: Inhaled GFF (PT003)

Drug: Inhaled BGF (PT010) Dose 2

Drug: Inhaled BGF (PT010) Dose 1

Drug: Inhaled BGF (PT010) Dose 3

Drug: Inhaled Symbicort Dose 1