PharmacokineticsPhase 1NCT02030457
A Study to Investigate the Pharmacokinetics and Safety of Beclomethasone Dipropionate Administered by Breath-Actuated Inhaler and Metered-Dose Inhaler in Healthy Adults
A Phase 1 study testing Beclomethasone dipropionate BAI and Beclomethasone dipropionate MDI in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
This study is designed to compare the systemic exposure of orally inhaled beclomethasone dipropionate inhalation aerosol delivered via BAI to that delivered via MDI. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Beclomethasone dipropionate BAI and Beclomethasone dipropionate MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2014
- 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
- The subject is a man or woman 18 through 45 years of age at the SV.
- The subject is assessed as being in good health based on a screening examination that includes medical history, physical examination (including a complete oropharyngeal examination), ECG assessment, and clinical laboratory results (ie, serum chemistry, hematology, and urinalysis).
- If female, subject is currently not pregnant, breast feeding, or attempting to become pregnant (for 30 days before the SV and throughout the duration of the study and for 30 days after subject's last visit), or is of non-childbearing potential, defined as any of the following:
- pre-menarche
- at least 1 year postmenopausal
- surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy)
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- congenital sterility
- diagnosed as infertile and not undergoing treatment to reverse infertility
- or is of childbearing potential, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
- systemic contraception used for at least 1 month before the SV including birth control pills, transdermal patch (Ortho Evra®, Janssen Pharmaceuticals Inc., or equivalent), vaginal ring (NuvaRing®, Merck \& Co., Inc., or equivalent), levonorgesterel implant (Norplant®, Population Council, or equivalent), or injectable progesterone (Depo-Provera®, Pfizer Inc., or equivalent)
- double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide)
- intrauterine device (IUD) with a low failure rate defined as less than 1% per year
- monogamous with a vasectomized male partner or same-sex female partner
- or is of childbearing potential and not sexually active, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active.
- If male, the subject is willing to commit to an acceptable method of birth control for the duration of the study, and for 3 months after dosing, or exclusively has same-sex partners.
- Subject is of normal body weight as evidenced by a BMI of at least 18 but no more than 30 kg/m2 (≥18 and ≤30 kg/m2), and has a body weight over 50 kg (>50 kg). The BMI is calculated as follows: weight (kg)/height2 (m).
- Subject does not have any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
- Other criteria may apply, please contact the investigator for more information.
Who cannot join
- Subject has clinically relevant abnormalities in clinical chemistry, hematology or any other laboratory variables.
- Subject has an irregular day/nighttime rhythm in daily living habits (eg, night work or repeated travels to places belonging to different time zones).
- Subject has been treated with any known cytochrome P450 3A4 (CYP3A4) inhibitor or inducers (eg, clarithromycin, ketoconazole, ritonavir, barbiturates, phenothiazines, cimetidine ) within 30 days before the Screening Visit (SV).
- Subject has been exposed to systemic corticosteroids (during the past 60 days) or intranasal/orally inhaled corticosteroids (during the past 30 days) for any indication, chronic or intermittent; or subject has an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
- Subject has used topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days before the SV; used a topical hydrocortisone or equivalent in any concentration covering greater than 20% of the body surface; or used any topical corticosteroids with an occlusive dressing; or has an underlying condition (as judged by the investigator) that can reasonably be expected to require treatment with such preparations during the course of the study.
- Subject has used any prohibited medication (see Section 5.3) within the prescribed period before the SV.
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- Subject is currently a smoker or has used any tobacco products within 1 year or has a >10-pack/year smoking history (ie, the equivalent of smoking 1 pack per day per 10 years).
- Subject has any piercings of the tongue, lips, or mouth.
- Other criteria may apply, please contact the investigator for more information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 3-Period Crossover, Single-Dose Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Beclomethasone Dipropionate (160 and 320 mcg) Delivered Via Breath-Actuated Inhaler (BAI) and Metered-Dose Inhaler (MDI) in Healthy Adult Subjects
This study is designed to compare the systemic exposure of orally inhaled beclomethasone dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.
- Conditions
- Pharmacokinetics
- Being tested
- Beclomethasone dipropionate BAI, Beclomethasone dipropionate MDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone dipropionate BAIDrug
Breath Activated Inhaler (BAI)
Beclomethasone dipropionate MDIDrug
Metered Dose Inhaler (MDI)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Treatment A: beclomethasone dipropionate BAI, 160 mcg - a single administration of 4 inhalations (40 mcg/inhalation) Receives: Drug: Beclomethasone dipropionate BAI; Drug: Beclomethasone dipropionate MDI |
| Treatment B | Experimental | Treatment B: beclomethasone dipropionate BAI, 320 mcg - a single administration of 4 inhalations (80 mcg/inhalation) Receives: Drug: Beclomethasone dipropionate BAI; Drug: Beclomethasone dipropionate MDI |
| Treatment C | Experimental | Treatment C: beclomethasone dipropionate MDI, 320 mcg - a single administration of 4 inhalations (80 mcg/inhalation) Receives: Drug: Beclomethasone dipropionate BAI; Drug: Beclomethasone dipropionate MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time (AUC0-t)
At each treatment period
Measured: Baseline, up to 24 hours
Maximum observed plasma drug concentration (Cmax)
At each treatment period
Measured: Baseline, up to 24 hours
Secondary outcomes (4)
Area under the plasma drug concentration-time (AUC0-∞)
At each treatment period
Measured: Baseline, up to 24 hours
Time to maximum observed plasma drug concentration (tmax)
At each treatment period
Measured: Baseline, up to 24 hours
Terminal elimination half-life (t½)
At each treatment period
Measured: Baseline, up to 24 hours
Summary of Participants with Adverse Events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030457
- Sponsor's protocol ID
- BDB-AS-101
- Status last verified
- Nov 2021
- First submitted
- 6 Jan 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 3-Period Crossover, Single-Dose Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Beclomethasone Dipropionate (160 and 320 mcg) Delivered Via Breath-Actuated Inhaler (BAI) and Metered-Dose Inhaler (MDI) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02030457
- Acronym / sponsor ID
- BDB-AS-101
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jan 2014 (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 study is designed to compare the systemic exposure of orally inhaled beclomethasone dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Beclomethasone dipropionate BAI, Drug: Beclomethasone dipropionate MDITreatment A: beclomethasone dipropionate BAI, 160 mcg - a single administration of 4 inhalations (40 mcg/inhalation) |
| Treatment B | Experimental | Drug: Beclomethasone dipropionate BAI, Drug: Beclomethasone dipropionate MDITreatment B: beclomethasone dipropionate BAI, 320 mcg - a single administration of 4 inhalations (80 mcg/inhalation) |
| Treatment C | Experimental | Drug: Beclomethasone dipropionate BAI, Drug: Beclomethasone dipropionate MDITreatment C: beclomethasone dipropionate MDI, 320 mcg - a single administration of 4 inhalations (80 mcg/inhalation) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- The subject is a man or woman 18 through 45 years of age at the SV.
- The subject is assessed as being in good health based on a screening examination that includes medical history, physical examination (including a complete oropharyngeal examination), ECG assessment, and clinical laboratory results (ie, serum chemistry, hematology, and urinalysis).
- If female, subject is currently not pregnant, breast feeding, or attempting to become pregnant (for 30 days before the SV and throughout the duration of the study and for 30 days after subject's last visit), or is of non-childbearing potential, defined as any of the following:
- Subject is of normal body weight as evidenced by a BMI of at least 18 but no more than 30 kg/m2 (≥18 and ≤30 kg/m2), and has a body weight over 50 kg (>50 kg). The BMI is calculated as follows: weight (kg)/height2 (m).
- Subject does not have any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
Key exclusion criteria (9 listed)
- Subject has clinically relevant abnormalities in clinical chemistry, hematology or any other laboratory variables.
- Subject has an irregular day/nighttime rhythm in daily living habits (eg, night work or repeated travels to places belonging to different time zones).
- Subject has been treated with any known cytochrome P450 3A4 (CYP3A4) inhibitor or inducers (eg, clarithromycin, ketoconazole, ritonavir, barbiturates, phenothiazines, cimetidine ) within 30 days before the Screening Visit (SV).
- Subject has been exposed to systemic corticosteroids (during the past 60 days) or intranasal/orally inhaled corticosteroids (during the past 30 days) for any indication, chronic or intermittent; or subject has an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
- Subject has used topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days before the SV; used a topical hydrocortisone or equivalent in any concentration covering greater than 20% of the body surface; or used any topical corticosteroids with an occlusive dressing; or has an underlying condition (as judged by the investigator) that can reasonably be expected to require treatment with such preparations during the course of the study.
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 |
|---|---|---|
| Beclomethasone dipropionate BAIBreath Activated Inhaler (BAI) | Drug | Treatment A, Treatment B, Treatment C |
| Beclomethasone dipropionate MDIMetered Dose Inhaler (MDI) | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Area under the plasma drug concentration-time (AUC0-t)
Time frame: Baseline, up to 24 hours
At each treatment period
Maximum observed plasma drug concentration (Cmax)
Time frame: Baseline, up to 24 hours
At each treatment period
4 secondary outcomes
Area under the plasma drug concentration-time (AUC0-∞)
Time frame: Baseline, up to 24 hours
Time to maximum observed plasma drug concentration (tmax)
Time frame: Baseline, up to 24 hours
Terminal elimination half-life (t½)
Time frame: Baseline, up to 24 hours
Summary of Participants with Adverse Events
Time frame: 16 weeks
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 9 Nov 2021.
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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.
Medical Director, MD study director
Teva Branded Pharmaceutical Products R&D, 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 Beclomethasone dipropionate BAI and Beclomethasone dipropionate MDI in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, 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 18 inclusion and 9 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 9 Nov 2021. 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?
Area under the plasma drug concentration-time (AUC0-t) (time frame: Baseline, up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2021.