- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00989391
A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth
December 15, 2009 updated by: Pfizer
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03654764 In Healthy Subjects
The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given once or twice daily by mouth for 10 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 188770
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects. (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).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Subjects will be assigned to receive either PF-03654764 or placebo.
|
5mg orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
12mg orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
12mg orally twice daily on Days 1-9, and once on Day 10 After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
oral twice daily on Days 1-9 and once on Day 10.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
|
Experimental: Cohort 2
Subjects will be assigned to receive either PF-03654764 or placebo.
|
5mg orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
12mg orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
12mg orally twice daily on Days 1-9, and once on Day 10 After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
oral twice daily on Days 1-9 and once on Day 10.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
|
Experimental: Cohort 3
Subjects will be assigned to receive either PF-03654764 or placebo.
|
5mg orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
12mg orally once daily for 10 days.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
12mg orally twice daily on Days 1-9, and once on Day 10 After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
oral twice daily on Days 1-9 and once on Day 10.
After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated.
If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped.
The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK.
Nominal administered doses will not exceed 24 mg per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination.
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, AUCtau (Day 10)/AUCtau (Day 1), CL/F
Time Frame: 10 days
|
10 days
|
Urine pharmacokinetics: Ae24 & Ae24% (for once daily doses) or Ae12 & Ae12% (for twice daily dose) on Day 10, CLR
Time Frame: 10 days
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
October 2, 2009
First Submitted That Met QC Criteria
October 2, 2009
First Posted (Estimate)
October 5, 2009
Study Record Updates
Last Update Posted (Estimate)
December 16, 2009
Last Update Submitted That Met QC Criteria
December 15, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- B0711002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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