HealthyPhase 1NCT01396135
A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects
A Phase 1 study testing CP-601,927 in people with Healthy, run by Pfizer.
Trial summary
This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects. 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?
- CP-601,927
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2011to 29 Oct 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 male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
- Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- 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 the time of dosing).
- Females of childbearing potential.
- Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations >100 ng/mL at any time during the study will be excluded.
About this study
Official title: A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects
This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.
- Conditions
- Healthy
- Being tested
- CP-601,927, Placebo
- Keywords
- Phase 1, Pharmacokinetics, Healthy, Japanese, Non-smokers, Major Depressive Disorder, CP-601, 927
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-601,927Drug
Single dose of 1 mg CP-601,927 given as oral 1 mg tablets
CP-601,927Drug
Single dose of 2 mg CP-601,927 given as oral 1 mg tablets
CP-601,927Drug
Single dose of 3 mg CP-601,927 given as oral 1 mg tablets
PlaceboDrug
Single dose of placebo given as a matching number of oral tablets
CP-601,927Drug
Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days
PlaceboDrug
Multiple doses of placebo given as a matching number of oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Single dosing | Experimental | Single doses of CP-601,927 (1, 2 or 3 mg) or placebo Receives: Drug: CP-601,927; Drug: Placebo |
| Multiple dosing | Experimental | Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo Receives: Drug: CP-601,927; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927
Measured: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927
Measured: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927
Measured: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
Measured: Day1-7
Suicidality assessment after single dose of 1 mg CP-601,927
Measured: Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 2 mg CP-601,927
Measured: Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 3 mg CP-601,927
Measured: Day 0, 0 and 2 hours post-dose
Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
Measured: Day1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study start26 Aug 2011
- Primary completion29 Oct 2011 (estimated)
- Study completion29 Oct 2011 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396135
- Sponsor's protocol ID
- A3331019
- Status last verified
- Oct 2018
- First submitted
- 14 Jul 2011
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01396135
- Acronym / sponsor ID
- A3331019
- Conditions
- Healthy
- Keywords
- Phase 1, Pharmacokinetics, Healthy, Japanese, Non-smokers, Major Depressive Disorder, CP-601, 927
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2011 (actual)
- Primary completion
- 29 Oct 2011 (estimated)
- Study completion
- 29 Oct 2011 (estimated)
- First posted
- 18 Jul 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.
This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dosing | Experimental | Drug: CP-601,927, Drug: PlaceboSingle doses of CP-601,927 (1, 2 or 3 mg) or placebo |
| Multiple dosing | Experimental | Drug: CP-601,927, Drug: PlaceboMultiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
- Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
- 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)
- 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 the time of dosing).
- Females of childbearing potential.
- Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations >100 ng/mL at any time during the study will be excluded.
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 |
|---|---|---|
| CP-601,927Single dose of 1 mg CP-601,927 given as oral 1 mg tablets | Drug | Single dosing |
| CP-601,927Single dose of 2 mg CP-601,927 given as oral 1 mg tablets | Drug | Single dosing |
| CP-601,927Single dose of 3 mg CP-601,927 given as oral 1 mg tablets | Drug | Single dosing |
| PlaceboSingle dose of placebo given as a matching number of oral tablets | Drug | Single dosing |
| CP-601,927Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days | Drug | Multiple dosing |
| PlaceboMultiple doses of placebo given as a matching number of oral tablets | Drug | Multiple dosing |
Primary outcome
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927
Time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927
Time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927
Time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
Time frame: Day1-7
Suicidality assessment after single dose of 1 mg CP-601,927
Time frame: Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 2 mg CP-601,927
Time frame: Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 3 mg CP-601,927
Time frame: Day 0, 0 and 2 hours post-dose
Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
Time frame: Day1-7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-601,927 in people with Healthy, run by Pfizer.
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 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: withdrawn, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927 (time frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose). The study lists 8 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 30 Oct 2018.