HealthyPhase 1NCT01051232
A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
A Phase 1 study testing Active in people with Healthy, run by Pfizer at 1 site in Japan.
Trial summary
A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Apr 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between the ages of 20 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
Who cannot join
- A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
- Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- Pregnant or nursing females; females of childbearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers
A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.
Read the detailed description
Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.
- Conditions
- Healthy
- Being tested
- Active, Placebo
- Keywords
- filibuvir, pharmacokinetics, Japanese, Asian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDrug
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
PlaceboDrug
Two subjects will receive the placebo under fasting condition.
ActiveDrug
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
PlaceboDrug
Two subjects will receive the placebo under fasting condition.
ActiveDrug
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
PlaceboDrug
Two subjects will receive the placebo under fasting condition.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Placebo comparator | PF-00868554 (filibuvir) 100 mg or placebo Receives: Drug: Active; Drug: Placebo |
| Cohort 2 | Placebo comparator | PF-00868554 (filibuvir) 300 mg or placebo Receives: Drug: Active; Drug: Placebo |
| Cohort 3 | Placebo comparator | PF-00868554 (filibuvir) 500 mg or placebo Receives: Drug: Active; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety; ECGs/vital signs
Measured: Screening to Follow-up (Day 5)
Safety; laboratory tests
Measured: Screening to Follow-up (Day 5)
Safety; physical examination/adverse event monitoring
Measured: Screening to Follow-up (Day 5)
Secondary outcomes (2)
Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations
Measured: Day 1 to Day 3
Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations
Measured: Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionApr 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
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
- NCT01051232
- Sponsor's protocol ID
- A8121035
- Status last verified
- Apr 2010
- First submitted
- 14 Jan 2010
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01051232
- Acronym / sponsor ID
- A8121035
- Conditions
- Healthy
- Keywords
- filibuvir, pharmacokinetics, Japanese, Asian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Jan 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.
A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.
Detailed description
Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Placebo comparator | Drug: Active, Drug: PlaceboPF-00868554 (filibuvir) 100 mg or placebo |
| Cohort 2 | Placebo comparator | Drug: Active, Drug: PlaceboPF-00868554 (filibuvir) 300 mg or placebo |
| Cohort 3 | Placebo comparator | Drug: Active, Drug: PlaceboPF-00868554 (filibuvir) 500 mg or placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects between the ages of 20 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
Key exclusion criteria (3 listed)
- A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
- Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- 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 |
|---|---|---|
| ActiveSix subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition. | Drug | Cohort 1 |
| PlaceboTwo subjects will receive the placebo under fasting condition. | Drug | Cohort 1 |
| ActiveSix subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition. | Drug | Cohort 2 |
| PlaceboTwo subjects will receive the placebo under fasting condition. | Drug | Cohort 2 |
| ActiveSix subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition. | Drug | Cohort 3 |
| PlaceboTwo subjects will receive the placebo under fasting condition. | Drug | Cohort 3 |
Primary outcome
Safety; ECGs/vital signs
Time frame: Screening to Follow-up (Day 5)
Safety; laboratory tests
Time frame: Screening to Follow-up (Day 5)
Safety; physical examination/adverse event monitoring
Time frame: Screening to Follow-up (Day 5)
2 secondary outcomes
Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations
Time frame: Day 1 to Day 3
Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations
Time frame: Day 1 to Day 3
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 26 Apr 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 Active in people with Healthy, run by Pfizer at 1 site in Japan.
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 3 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 26 Apr 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 Japan. 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?
Safety; ECGs/vital signs (time frame: Screening to Follow-up (Day 5)). The study lists 3 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 26 Apr 2010.