HealthyPhase 1NCT01140425
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
A Phase 1 study testing PF-00232798 and Moxifloxacin in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-00232798 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2010to Dec 2010
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- 12-lead ECG demonstrating QTc >450 msec at screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- History of orthostatic symptoms or orthostatic hypotension at screening.
- Pregnant or nursing females; females of childbearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects
The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.
- Conditions
- Healthy
- Being tested
- PF-00232798, Placebo, Moxifloxacin
- Keywords
- PF-00232798, CCR5, QT, QTc, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00232798Drug
600 mg oral solution once daily x 7 days
PF-00232798Drug
300 mg oral solution once daily x 7 days
PlaceboDrug
Oral solution once daily x 7 days
MoxifloxacinDrug
400 mg tablet single dose
| Study group | Role | What they receive |
|---|---|---|
| PF-00232798 supratherapeutic dose | Experimental | PF-00232798 supratherapeutic dose Receives: Drug: PF-00232798 |
| PF-00232798 therapeutic dose | Experimental | PF-00232798 therapeutic dose Receives: Drug: PF-00232798 |
| Placebo for PF-00232798 | Placebo comparator | Placebo for PF-00232798 Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
Measured: 7 days
Secondary outcomes (4)
QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7
Measured: 7 days
QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7
Measured: 7 days
Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)
Measured: 7 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140425
- Sponsor's protocol ID
- A7691017
- Status last verified
- Dec 2010
- First submitted
- 7 Jun 2010
- Last updated
- 23 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01140425
- Acronym / sponsor ID
- A7691017
- Conditions
- Healthy
- Keywords
- PF-00232798, CCR5, QT, QTc, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Jun 2010 (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 purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-00232798 supratherapeutic dose | Experimental | Drug: PF-00232798PF-00232798 supratherapeutic dose |
| PF-00232798 therapeutic dose | Experimental | Drug: PF-00232798PF-00232798 therapeutic dose |
| Placebo for PF-00232798 | Placebo comparator | Drug: PlaceboPlacebo for PF-00232798 |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (5 listed)
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- 12-lead ECG demonstrating QTc >450 msec at screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- History of orthostatic symptoms or orthostatic hypotension at screening.
- Pregnant or nursing females; females of childbearing potential.
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 |
|---|---|---|
| PF-00232798600 mg oral solution once daily x 7 days | Drug | PF-00232798 supratherapeutic dose |
| PF-00232798300 mg oral solution once daily x 7 days | Drug | PF-00232798 therapeutic dose |
| PlaceboOral solution once daily x 7 days | Drug | Placebo for PF-00232798 |
| Moxifloxacin400 mg tablet single dose | Drug | Moxifloxacin |
Primary outcome
QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
Time frame: 7 days
4 secondary outcomes
QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7
Time frame: 7 days
QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7
Time frame: 7 days
Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)
Time frame: 7 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
Time frame: 7 days
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 23 Dec 2010.
- 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 PF-00232798 and Moxifloxacin in people with Healthy, run by Pfizer at 1 site in Singapore.
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 2 inclusion and 5 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 23 Dec 2010. 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 Singapore. 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?
QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7. (time frame: 7 days). 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 23 Dec 2010.