Healthy VolunteersPhase 1NCT01980615
Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
A Phase 1 study testing Inhaled BGF (PT010) Dose 1, Inhaled BGF (PT010) Dose 2 and Inhaled BGF (PT010) Dose 3 in people with Healthy Volunteers, run by Pearl Therapeutics, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Inhaled BGF (PT010) Dose 1, Inhaled BGF (PT010) Dose 2 and Inhaled BGF (PT010) Dose 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Inhaled BGF (PT010) Dose 1, Inhaled BGF (PT010) Dose 2, Inhaled BGF (PT010) Dose 3, Inhaled GFF (PT003), Inhaled Symbicort Dose 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled BGF (PT010) Dose 1Drug
Inhaled BGF (PT010) Dose 2Drug
Inhaled BGF (PT010) Dose 3Drug
Inhaled GFF (PT003)Drug
Inhaled Symbicort Dose 1Drug
Inhaled Symbicort Dose 2Drug
| Study group | Role | What they receive |
|---|---|---|
| BGF MDI (PT010) Dose 1 | Experimental | BGF MDI Dose 1 taken as 2 inhalations Receives: Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled BGF (PT010) Dose 3; Drug: Inhaled GFF (PT003); Drug: Inhaled Symbicort Dose 1; Drug: Inhaled Symbicort Dose 2 |
| BGF MDI (PT010) Dose 2 | Experimental | BGF MDI Dose 2 taken as 2 inhalations Receives: 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 |
| BGF MDI (PT010) Dose 3 | Experimental | BGF MDI Dose 3 taken as 2 inhalations Receives: Drug: Inhaled BGF (PT010) Dose 1; Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled GFF (PT003); Drug: Inhaled Symbicort Dose 1; Drug: Inhaled Symbicort Dose 2 |
| GFF MDI (PT003) | Active comparator | GFF MDI (PT003) taken as 2 inhalations Receives: Drug: Inhaled BGF (PT010) Dose 1; Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled BGF (PT010) Dose 3; Drug: Inhaled Symbicort Dose 1; Drug: Inhaled Symbicort Dose 2 |
| Symbicort MDI Dose 1 | Active comparator | Symbicort MDI taken as 2 inhalations Receives: Drug: Inhaled BGF (PT010) Dose 1; Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled BGF (PT010) Dose 3; Drug: Inhaled GFF (PT003); Drug: Inhaled Symbicort Dose 2 |
| Symbicort MDI Dose 2 | Active comparator | Symbicort MDI Dose 2 taken as 2 inhalations Receives: Drug: Inhaled BGF (PT010) Dose 1; Drug: Inhaled BGF (PT010) Dose 2; Drug: Inhaled BGF (PT010) Dose 3; Drug: Inhaled GFF (PT003); Drug: Inhaled Symbicort Dose 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall safety of BGF, GFF, and Symbicort MDI based on the group of outcome measures for safety.
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).
Measured: 12 hours following study drug administration
Secondary outcomes (1)
Overall pharmacokinetic profile of BGF, GFF, and Symbicort MDI based on the group of outcome measures for pharmacokinetics.
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.
Measured: 12 hours following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Reisner, MD, Study chair, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980615
- Sponsor's protocol ID
- PT010001-00
- Status last verified
- Apr 2014
- First submitted
- 21 Oct 2013
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33152467Darken 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.
PubMed 29544728
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01980615
- Acronym / sponsor ID
- PT010001-00
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BGF MDI (PT010) Dose 1 | Experimental | Drug: Inhaled BGF (PT010) Dose 2, Drug: Inhaled BGF (PT010) Dose 3, Drug: Inhaled GFF (PT003), Drug: Inhaled Symbicort Dose 1, Drug: Inhaled Symbicort Dose 2BGF MDI Dose 1 taken as 2 inhalations |
| BGF MDI (PT010) Dose 2 | Experimental | 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 2BGF MDI Dose 2 taken as 2 inhalations |
| BGF MDI (PT010) Dose 3 | Experimental | Drug: Inhaled BGF (PT010) Dose 1, Drug: Inhaled BGF (PT010) Dose 2, Drug: Inhaled GFF (PT003), Drug: Inhaled Symbicort Dose 1, Drug: Inhaled Symbicort Dose 2BGF MDI Dose 3 taken as 2 inhalations |
| GFF MDI (PT003) | Active comparator | Drug: Inhaled BGF (PT010) Dose 1, Drug: Inhaled BGF (PT010) Dose 2, Drug: Inhaled BGF (PT010) Dose 3, Drug: Inhaled Symbicort Dose 1, Drug: Inhaled Symbicort Dose 2GFF MDI (PT003) taken as 2 inhalations |
| Symbicort MDI Dose 1 | Active comparator | Drug: Inhaled BGF (PT010) Dose 1, Drug: Inhaled BGF (PT010) Dose 2, Drug: Inhaled BGF (PT010) Dose 3, Drug: Inhaled GFF (PT003), Drug: Inhaled Symbicort Dose 2Symbicort MDI taken as 2 inhalations |
| Symbicort MDI Dose 2 | Active comparator | Drug: Inhaled BGF (PT010) Dose 1, Drug: Inhaled BGF (PT010) Dose 2, Drug: Inhaled BGF (PT010) Dose 3, Drug: Inhaled GFF (PT003), Drug: Inhaled Symbicort Dose 1Symbicort MDI Dose 2 taken as 2 inhalations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled BGF (PT010) Dose 1 | Drug | BGF MDI (PT010) Dose 2, BGF MDI (PT010) Dose 3, GFF MDI (PT003), Symbicort MDI Dose 1, Symbicort MDI Dose 2 |
| Inhaled BGF (PT010) Dose 2 | Drug | BGF MDI (PT010) Dose 1, BGF MDI (PT010) Dose 3, GFF MDI (PT003), Symbicort MDI Dose 1, Symbicort MDI Dose 2 |
| Inhaled BGF (PT010) Dose 3 | Drug | BGF MDI (PT010) Dose 1, BGF MDI (PT010) Dose 2, GFF MDI (PT003), Symbicort MDI Dose 1, Symbicort MDI Dose 2 |
| Inhaled GFF (PT003) | Drug | BGF MDI (PT010) Dose 1, BGF MDI (PT010) Dose 2, BGF MDI (PT010) Dose 3, Symbicort MDI Dose 1, Symbicort MDI Dose 2 |
| Inhaled Symbicort Dose 1 | Drug | BGF MDI (PT010) Dose 1, BGF MDI (PT010) Dose 2, BGF MDI (PT010) Dose 3, GFF MDI (PT003), Symbicort MDI Dose 2 |
| Inhaled Symbicort Dose 2 | Drug | BGF MDI (PT010) Dose 1, BGF MDI (PT010) Dose 2, BGF MDI (PT010) Dose 3, GFF MDI (PT003), Symbicort MDI Dose 1 |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Derived from this study: PubMed 33152467Huang 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.
- Derived from this study: PubMed 29544728Darken 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Reisner, MD study chair
Pearl Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled BGF (PT010) Dose 1, Inhaled BGF (PT010) Dose 2 and Inhaled BGF (PT010) Dose 3 in people with Healthy Volunteers, run by Pearl Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.