HealthyPhase 1NCT03121664
A Study To Estimate The Effects Of Itraconazole On Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects
A Phase 1 study testing PF06649751, Itraconazole in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy 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?
- PF06649751, Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Apr 2017to 14 Sep 2017
- 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
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
- Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
- Unwilling or unable to comply with the Lifestyle Requirements described in this protocol
- Subjects who had a history of allergy or intolerance to azole antifungal drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Fixed-sequence Study To Estimate The Effects Of Multiple-dose Administration Of Itraconazole On The Steady-state Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects
The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy subjects
- Conditions
- Healthy
- Being tested
- PF06649751, Itraconazole
- Keywords
- Drug drug interaction, CYP3A4, itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF06649751, ItraconazoleDrug
PF-06649751 0.25 mg on Days 1,2,3 PF-06649751 0.5 mg on Days 4,5,6 PF-06649751 1 mg on Days 7 to Day 25 Itracoanzole 200 mg on Days 12 to Day 25
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: PF06649751, Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PF-06649751 and PF-06752844 steady state Cmax
Maximum Observed Plasma Concentration
Measured: Day 11 and Day 25
PF-06649751 and PF-06752844 steady state AUC24
Area Under the Curve From Time Zero to the end of the dosing period
Measured: Days 11 and Day 25
Secondary outcomes (6)
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day 0
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day 7
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day 14
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day 21
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assess whether participant experience the following: completed suicide (1), suicide attempt (2) (response "YES" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("yes" on "preparatory acts or behavior"), suicidal ideation (4) ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific pan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: Day 26
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Y days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug X was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Day 1 to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start7 Apr 2017
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT03121664
- Sponsor's protocol ID
- B7601006
- Other IDs
- 2016-005201-39, 2016
- Status last verified
- Nov 2017
- First submitted
- 7 Apr 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed-sequence Study To Estimate The Effects Of Multiple-dose Administration Of Itraconazole On The Steady-state Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03121664
- Acronym / sponsor ID
- B7601006
- Conditions
- Healthy
- Keywords
- Drug drug interaction, CYP3A4, itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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 evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy subjects
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF06649751, Itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
- Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
- Unwilling or unable to comply with the Lifestyle Requirements described in this protocol
- Subjects who had a history of allergy or intolerance to azole antifungal drugs
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 |
|---|---|---|
| PF06649751, ItraconazolePF-06649751 0.25 mg on Days 1,2,3 PF-06649751 0.5 mg on Days 4,5,6 PF-06649751 1 mg on Days 7 to Day 25 Itracoanzole 200 mg on Days 12 to Day 25 | Drug | Cohort 1 |
Primary outcome
PF-06649751 and PF-06752844 steady state Cmax
Time frame: Day 11 and Day 25
Maximum Observed Plasma Concentration
PF-06649751 and PF-06752844 steady state AUC24
Time frame: Days 11 and Day 25
Area Under the Curve From Time Zero to the end of the dosing period
6 secondary outcomes
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 0
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 7
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 14
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 21
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Day 26
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Day 1 to Day 26
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 6 Nov 2017.
- 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
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 PF06649751, Itraconazole in people with Healthy, run by Pfizer at 1 site in Belgium.
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 6 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 6 Nov 2017. 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 Belgium. 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 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?
PF-06649751 and PF-06752844 steady state Cmax (time frame: Day 11 and Day 25). The study lists 2 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 6 Nov 2017.