Healthy VolunteersPhase 1NCT00875628
A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
A Phase 1 study of Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2009
- 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 Japanese subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- Pregnant or nursing females; females of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Glendale, California, 91206
About this study
Official title: A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
Read the detailed description
Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.
- Conditions
- Healthy Volunteers
- Being tested
- PF-00868554 or Placebo
- Keywords
- Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00868554 or PlaceboDrug
Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
PF-00868554 or PlaceboDrug
Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
PF-00868554 or PlaceboDrug
Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | PF-00868554 100 mg or placebo Receives: Drug: PF-00868554 or Placebo |
| Cohort 2 | Other | PF-00868554 300 mg or placebo Receives: Drug: PF-00868554 or Placebo |
| Cohort 3 | Other | PF-00868554 600 mg or placebo Receives: Drug: PF-00868554 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PF-00868554 concentrations
Measured: Day 1-Day 17
Urine PF-00868554 concentrations
Measured: Day 1 and Day 14
Adverse event monitoring and Physical examination
Measured: Day 0-Day 17
ECGs and vital signs (Blood pressure and Pulse rate)
Measured: Day 1-Day 17
Clinical safety laboratory tests
Measured: Day 0, Day 7, and Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: See Detailed Description
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, 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
- NCT00875628
- Sponsor's protocol ID
- A8121018
- Status last verified
- Oct 2009
- First submitted
- 1 Apr 2009
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00875628
- Acronym / sponsor ID
- A8121018
- Conditions
- Healthy Volunteers
- Keywords
- Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 3 Apr 2009 (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.
Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
Detailed description
Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: PF-00868554 or PlaceboPF-00868554 100 mg or placebo |
| Cohort 2 | Other | Drug: PF-00868554 or PlaceboPF-00868554 300 mg or placebo |
| Cohort 3 | Other | Drug: PF-00868554 or PlaceboPF-00868554 600 mg or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female Japanese subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- 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-00868554 or PlaceboDosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days | Drug | Cohort 1 |
| PF-00868554 or PlaceboDosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days | Drug | Cohort 2 |
| PF-00868554 or PlaceboDosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days | Drug | Cohort 3 |
Primary outcome
Plasma PF-00868554 concentrations
Time frame: Day 1-Day 17
Urine PF-00868554 concentrations
Time frame: Day 1 and Day 14
Adverse event monitoring and Physical examination
Time frame: Day 0-Day 17
ECGs and vital signs (Blood pressure and Pulse rate)
Time frame: Day 1-Day 17
Clinical safety laboratory tests
Time frame: Day 0, Day 7, and Day 17
Results and safety
The study was stopped early (reason given: See Detailed Description). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
Pain
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 of 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 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: stopped early, as of the sponsor's last update on 22 Oct 2009. 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 was stopped early (reason given: See Detailed Description). Results are not available in the source record.
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?
Plasma PF-00868554 concentrations (time frame: Day 1-Day 17). The study lists 5 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 22 Oct 2009.