Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/30/2013 |
| Start Date: | January 2014 |
| End Date: | March 2014 |
| Contact: | Joe Covino |
| Phone: | 973-975-0325 |
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
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.
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
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