Healthy VolunteersPhase 1NCT02207699
Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
A Phase 1 study testing Benzonatate 200 mg, Benzonatate 800 mg and Moxifloxacin 400 mg in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The primary objective of this study is to determine the effects of benzonatate (200 mg and 800 mg) on the QT interval following single dose oral administration at each time point post-dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Benzonatate 200 mg, Benzonatate 800 mg and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12- lead ECG and clinical laboratory tests.
- Female subjects of non-childbearing potential must meet at least one of the following criteria:
- Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum FSH level within the laboratory's reference range for postmenopausal females;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all aspects of the study.
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Significant ECG abnormality at screening as determined by the investigator.
- History or risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
- 12-lead ECG demonstrating QTcF >450 msec or a QRS interval >110 msec at Screening.
- Use of medications or dietary supplements capable of inducing or inhibiting hepatic enzyme metabolism or transport (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone, or St. John's Wort) within 28 days of the first dose of study medication.
- Consumption of grapefruit or grapefruit containing products within 7 days prior to the first dose of study medication.
- Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to quinolone antibiotics.
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- Known hypersensitivity to benzonatate or other ester-type local anesthetics (ie, tetracaine, procaine).
- Subjects with a presence or history of dysphagia or difficulty swallowing pills.
- Subjects taking any concomitant anticonvulsant medications or with a history of seizure disorder.
- Subjects with a positive response to the question of actual attempt in the suicidal behavior section of the C-SSRS (Columbia-Suicide Severity Rating Scale). Subjects with active suicidal ideation with intent to act within 6 months of screening as determined by a positive response to questions 4 or 5 in the suicidal ideation section of the C-SSRS.
- Screening laboratory values considered clinically significant by the investigator.
- Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of rest.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
The primary objective of this study is to determine the effects of benzonatate (200 mg and 800 mg) on the QT interval following single dose oral administration at each time point post-dose.
- Conditions
- Healthy Volunteers
- Being tested
- Benzonatate 200 mg, Benzonatate 800 mg, Moxifloxacin 400 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzonatate 200 mgDrug
2 benzonatate 100 mg perles and 6 placebo perles give by mouth once
Benzonatate 800 mgDrug
8 benzonatate 100 mg perles given by mouth once
Moxifloxacin 400 mgDrug
1 moxifloxacin 400 mg tablet given by mouth once
PlaceboDrug
8 placebo perles given by mouth once
| Study group | Role | What they receive |
|---|---|---|
| Benzonatate 200 mg | Experimental | Not described Receives: Drug: Benzonatate 200 mg |
| Benzonatate 800 mg | Experimental | Not described Receives: Drug: Benzonatate 800 mg |
| Moxifloxacin 400 mg | Active comparator | Not described Receives: Drug: Moxifloxacin 400 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fridericia-corrected QTc change from the pre-dose time point to the post-dose time points following administration of study drug in therapeutic (200 mg) and supratherapeutic doses (800 mg).
Measured: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours
Secondary outcomes (12)
QT interval for Benzonatate, 4-(butylamino)benzoic acid (BBA-major metabolite of benzonatate), and moxifloxacin.
Measured: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours
PR interval, QRS complex from single 12-lead electrocardiogram (ECG)
Measured: Screening, Day 0, and Day 1 at 4, 8, and 24 hours after dosing
Cmax (maximum plasma concentration) for BT and BBA measured in mcg/mL
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Tmax (time of maximum plasma concentration) for BT and BBA measured in minutes
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
t½ (terminal half-life) for BT and BBA measured in minutes
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUClast for BT and BBA measured in mcg•hr/mL
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUCinf for BT and BBA measured in mcg•hr/mL
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Cmax(dn) for BT and BBA measured in mcg/mL
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUClast(dn) for BT and BBA measured in mcg•hr/mL
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUCinf(dn) for BT and BBA measured in mcg•hr/mL
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
CL/F for BT measured in L/hr
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Vz/F for BT measured in L
Measured: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207699
- Sponsor's protocol ID
- B3551003
- Other IDs
- BT-10-02
- Status last verified
- Jul 2014
- First submitted
- 16 Jun 2014
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02207699
- Acronym / sponsor ID
- B3551003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Aug 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.
The primary objective of this study is to determine the effects of benzonatate (200 mg and 800 mg) on the QT interval following single dose oral administration at each time point post-dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Benzonatate 200 mg | Experimental | Drug: Benzonatate 200 mg |
| Benzonatate 800 mg | Experimental | Drug: Benzonatate 800 mg |
| Moxifloxacin 400 mg | Active comparator | Drug: Moxifloxacin 400 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12- lead ECG and clinical laboratory tests.
- Female subjects of non-childbearing potential must meet at least one of the following criteria:
- Body mass index (BMI) of 17.5 to 30.5 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all aspects of the study.
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (12 listed)
- Significant ECG abnormality at screening as determined by the investigator.
- History or risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
- 12-lead ECG demonstrating QTcF >450 msec or a QRS interval >110 msec at Screening.
- Use of medications or dietary supplements capable of inducing or inhibiting hepatic enzyme metabolism or transport (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone, or St. John's Wort) within 28 days of the first dose of study medication.
- Consumption of grapefruit or grapefruit containing products within 7 days prior to the first dose of study medication.
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 |
|---|---|---|
| Benzonatate 200 mg2 benzonatate 100 mg perles and 6 placebo perles give by mouth once | Drug | Benzonatate 200 mg |
| Benzonatate 800 mg8 benzonatate 100 mg perles given by mouth once | Drug | Benzonatate 800 mg |
| Moxifloxacin 400 mg1 moxifloxacin 400 mg tablet given by mouth once | Drug | Moxifloxacin 400 mg |
| Placebo8 placebo perles given by mouth once | Drug | Placebo |
Primary outcome
Fridericia-corrected QTc change from the pre-dose time point to the post-dose time points following administration of study drug in therapeutic (200 mg) and supratherapeutic doses (800 mg).
Time frame: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours
12 secondary outcomes
QT interval for Benzonatate, 4-(butylamino)benzoic acid (BBA-major metabolite of benzonatate), and moxifloxacin.
Time frame: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours
PR interval, QRS complex from single 12-lead electrocardiogram (ECG)
Time frame: Screening, Day 0, and Day 1 at 4, 8, and 24 hours after dosing
Cmax (maximum plasma concentration) for BT and BBA measured in mcg/mL
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Tmax (time of maximum plasma concentration) for BT and BBA measured in minutes
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
t½ (terminal half-life) for BT and BBA measured in minutes
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUClast for BT and BBA measured in mcg•hr/mL
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUCinf for BT and BBA measured in mcg•hr/mL
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Cmax(dn) for BT and BBA measured in mcg/mL
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUClast(dn) for BT and BBA measured in mcg•hr/mL
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
AUCinf(dn) for BT and BBA measured in mcg•hr/mL
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
CL/F for BT measured in L/hr
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
Vz/F for BT measured in L
Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, and 12 hours
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 4 Aug 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Benzonatate 200 mg, Benzonatate 800 mg and Moxifloxacin 400 mg in people with Healthy Volunteers, run by Pfizer 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 8 inclusion and 12 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 4 Aug 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. Some participants in this study may receive a placebo. 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?
Fridericia-corrected QTc change from the pre-dose time point to the post-dose time points following administration of study drug in therapeutic (200 mg) and supratherapeutic doses (800 mg). (time frame: -1, -0.75, -0.5, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours). 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 4 Aug 2014.