HealthyPhase 1NCT01287793
Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
A Phase 1 study testing tigecycline, moxifloxacin and 100 mL 0.9% Sodium Chloride intravenous in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tigecycline, moxifloxacin and 100 mL 0.9% Sodium Chloride intravenous
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2011
- 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
- Body mass index 17.5 - 30.5 kg
- Total body weight greater than 50 kg
Who cannot join
- Recent history of diarrhea
- Use of oral antibiotics in the last 2 weeks
- History of risk factors for QT prolongation pregnant females
- Nursing females
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: Randomized, 4-Way, Crossover Single Dose, Placebo And Active Controlled Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.
Read the detailed description
evaluation of effect of tigecycline on QT/QTc in healthy volunteers
- Conditions
- Healthy
- Being tested
- tigecycline, moxifloxacin, 100 mL 0.9% Sodium Chloride intravenous, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tigecyclineDrug
Also called Tygacil, GAR-936
intravenous, 200 mg, single dose
tigecyclineDrug
Also called Tygacil, GAR-936
intravenous, 50 mg, single dose
moxifloxacinDrug
oral tablet, 400 mg, single dose
100 mL 0.9% Sodium Chloride intravenousDrug
intravenous fluid, 100 mL, single dose
placeboDrug
0.9% Sodium Chloride intravenous 100mL, single dose
| Study group | Role | What they receive |
|---|---|---|
| high dose tigecycline | Experimental | Not described Receives: Drug: tigecycline |
| regular dose tigecycline | Experimental | Not described Receives: Drug: tigecycline |
| moxifloxacin | Active comparator | Not described Receives: Drug: moxifloxacin; Drug: 100 mL 0.9% Sodium Chloride intravenous |
| 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.
Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
Measured: Up to 96 hours
Secondary outcomes (10)
QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods
Measured: -2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Maximum concentration pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Time of maximum concentration pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Elimination rate constant pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Half life pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Clearance pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Response-exposure relationships between QT/QTc and tigecycline concentration
Measured: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287793
- Sponsor's protocol ID
- B1811062
- Status last verified
- May 2011
- First submitted
- 21 Jan 2011
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Korth-Bradley JM, McGovern PC, Salageanu J, Matschke K, Plotka A, Pawlak S. Tigecycline does not prolong corrected QT intervals in healthy subjects. Antimicrob Agents Chemother. 2013 Apr;57(4):1895-901. doi: 10.1128/AAC.01576-12. Epub 2013 Feb 12.
PubMed 23403419
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 4-Way, Crossover Single Dose, Placebo And Active Controlled Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01287793
- Acronym / sponsor ID
- B1811062
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Feb 2011 (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.
Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.
Detailed description
evaluation of effect of tigecycline on QT/QTc in healthy volunteers
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high dose tigecycline | Experimental | Drug: tigecycline |
| regular dose tigecycline | Experimental | Drug: tigecycline |
| moxifloxacin | Active comparator | Drug: moxifloxacin, Drug: 100 mL 0.9% Sodium Chloride intravenous |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Body mass index 17.5 - 30.5 kg
- Total body weight greater than 50 kg
Key exclusion criteria (4 listed)
- Recent history of diarrhea
- Use of oral antibiotics in the last 2 weeks
- History of risk factors for QT prolongation pregnant females
- Nursing females
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 |
|---|---|---|
| tigecyclineAlso: Tygacil, GAR-936intravenous, 200 mg, single dose | Drug | high dose tigecycline |
| tigecyclineAlso: Tygacil, GAR-936intravenous, 50 mg, single dose | Drug | regular dose tigecycline |
| moxifloxacinoral tablet, 400 mg, single dose | Drug | moxifloxacin |
| 100 mL 0.9% Sodium Chloride intravenousintravenous fluid, 100 mL, single dose | Drug | moxifloxacin |
| placebo0.9% Sodium Chloride intravenous 100mL, single dose | Drug | placebo |
Primary outcome
Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
Time frame: Up to 96 hours
10 secondary outcomes
QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods
Time frame: -2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Maximum concentration pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Time of maximum concentration pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Elimination rate constant pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Half life pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Clearance pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Response-exposure relationships between QT/QTc and tigecycline concentration
Time frame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 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 24 May 2011.
- Derived from this study: PubMed 23403419Korth-Bradley JM, McGovern PC, Salageanu J, Matschke K, Plotka A, Pawlak S. Tigecycline does not prolong corrected QT intervals in healthy subjects. Antimicrob Agents Chemother. 2013 Apr;57(4):1895-901. doi: 10.1128/AAC.01576-12. Epub 2013 Feb 12.
- 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 tigecycline, moxifloxacin and 100 mL 0.9% Sodium Chloride intravenous in people with Healthy, 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 3 inclusion and 4 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 24 May 2011. 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?
Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses (time frame: Up to 96 hours). 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 NCT01287793, which also lists 1 linked publication.
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 24 May 2011.