HealthyPhase 1NCT02475746
An Open-label, Two-period, Fixed-sequence Study to Evaluate Multiple-dose Itraconazole Effect on The Single-dose PK of PF-06372865 in Healthy Subjects
A Phase 1 study testing PF-06372865 and itraconazole in people with Healthy, run by Pfizer at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of itraconazole after multiple dose administration on the single dose PK of PF-06372865. 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?
- PF-06372865 and itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Aug 2015
- 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 female subjects of non-childbearing potential and/or male subjects who, at the time of Screening, are between the ages of 18 and 55 years, inclusive. 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 or clinical laboratory tests
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
- 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, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Hypersensitivity or previous adverse events due to azole antifungals.
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Use of tobacco or nicotine containing products in the past 6 months, as evident by a positive urine Cotinine test at Screening.
- 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.
Show all 16Show fewer
- Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
- Subjects with ANY of the following abnormalities in clinical laboratory tests at Screening AND at Day 0, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) >1x upper limit of normal (ULN); Total bilirubin >1x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ULN.
- Pregnant female subjects; females of childbearing potential; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least two months after the last dose of Itraconazole
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of investigational product
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study
- Any condition possibly affecting drug absorption (eg, gastrectomy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
CRU New Haven
New Haven, Connecticut
About this study
Official title: A Phase 1, Open-label, Two-period, Fixed-sequence Study To Estimate The Effects Of Multiple-dose Administration Of Itraconazole On The Single-dose Pharmacokinetics Of Pf-06372865 In Healthy Adult Subjects
The purpose of this study is to evaluate the effect of itraconazole after multiple dose administration on the single dose PK of PF-06372865.
Read the detailed description
Study includes two treatment periods: period 1 is single dose of PF-06372865 given alone followed by at least 5-day washout out. The period 2 is 200 mg QD itraconazole given for 8 days with PF-06372865 single dose co-administered on day 4 (1 hour later than itraconazole dose). The PK and safety will be assessed and compared for single dose of PF-06372865 in period 1 and period 2.
- Conditions
- Healthy
- Being tested
- PF-06372865, itraconazole
- Keywords
- drug interaction, PF-06372865, itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06372865Drug
single dose of 7.5 mg PF-06372865 alone (period 1) or co-administered with itraconazole (period 2)
itraconazoleDrug
Interacting drug which will be given 200 mg QD for 8 days in period 2
| Study group | Role | What they receive |
|---|---|---|
| PF-06372865 treatment arm | Experimental | treatment arm includes two treatment periods, a single dose of PF-06372865 (period 1) followed by 8-days itraconazole with a single dose of PF-06372865 co-administered on Day 4 Receives: Drug: PF-06372865; Drug: itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax ratio of PF-06372865 alone vs coadministration with itraconazole
The ratio of maximum plasma concentration of PF-06372865 following single dose co-administered with itraconazole vs given alone
Measured: 0 to 120 hours post PF-06372865
AUC ratio of PF-06372865 alone vs coadministration with itraconazole
The ratio of AUC (area under plasma concentration curve) of PF-06372865 following single dose co-administered with itraconazole vs given alone
Measured: 0 to 120 hours post PF-06372865
PF-06372865 Tmax
Time to PF-06372865 maximum concentration following single dose co-administered with itraconazole or given alone
Measured: 0 to 120 hours post PF-06372865
T1/2 of PF-06372865 alone vs coadministration with itraconazole
T1/2 (half-life) of PF-06372865 following single dose co-administered with itraconazole or given alone
Measured: 0 to 120 hours post PF-06372865
CL/F of PF-06372865 alone vs coadministration with itraconazole
CL/F (oral clearance) of PF-06372865 following single dose co-administered with itraconazole or given alone
Measured: 0 to 120 hours post PF-06372865
Vz/F of PF-06372865 alone vs coadministration with itraconazole
Vz/F (volume distribution) of PF-06372865 following single dose co-administered with itraconazole or given alone
Measured: 0 to 120 hours post PF-06372865
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT02475746
- Sponsor's protocol ID
- B7431009
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2015
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Two-period, Fixed-sequence Study To Estimate The Effects Of Multiple-dose Administration Of Itraconazole On The Single-dose Pharmacokinetics Of Pf-06372865 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02475746
- Acronym / sponsor ID
- B7431009
- Conditions
- Healthy
- Keywords
- drug interaction, PF-06372865, itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 19 Jun 2015 (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.
The purpose of this study is to evaluate the effect of itraconazole after multiple dose administration on the single dose PK of PF-06372865.
Detailed description
Study includes two treatment periods: period 1 is single dose of PF-06372865 given alone followed by at least 5-day washout out. The period 2 is 200 mg QD itraconazole given for 8 days with PF-06372865 single dose co-administered on day 4 (1 hour later than itraconazole dose). The PK and safety will be assessed and compared for single dose of PF-06372865 in period 1 and period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-06372865 treatment arm | Experimental | Drug: PF-06372865, Drug: itraconazoletreatment arm includes two treatment periods, a single dose of PF-06372865 (period 1) followed by 8-days itraconazole with a single dose of PF-06372865 co-administered on Day 4 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of Screening, are between the ages of 18 and 55 years, inclusive. 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 or clinical laboratory tests
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
- 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
Key exclusion criteria (16 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 time of dosing)
- Hypersensitivity or previous adverse events due to azole antifungals.
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Use of tobacco or nicotine containing products in the past 6 months, as evident by a positive urine Cotinine test at Screening.
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-06372865single dose of 7.5 mg PF-06372865 alone (period 1) or co-administered with itraconazole (period 2) | Drug | PF-06372865 treatment arm |
| itraconazoleInteracting drug which will be given 200 mg QD for 8 days in period 2 | Drug | PF-06372865 treatment arm |
Primary outcome
Cmax ratio of PF-06372865 alone vs coadministration with itraconazole
Time frame: 0 to 120 hours post PF-06372865
The ratio of maximum plasma concentration of PF-06372865 following single dose co-administered with itraconazole vs given alone
AUC ratio of PF-06372865 alone vs coadministration with itraconazole
Time frame: 0 to 120 hours post PF-06372865
The ratio of AUC (area under plasma concentration curve) of PF-06372865 following single dose co-administered with itraconazole vs given alone
PF-06372865 Tmax
Time frame: 0 to 120 hours post PF-06372865
Time to PF-06372865 maximum concentration following single dose co-administered with itraconazole or given alone
T1/2 of PF-06372865 alone vs coadministration with itraconazole
Time frame: 0 to 120 hours post PF-06372865
T1/2 (half-life) of PF-06372865 following single dose co-administered with itraconazole or given alone
CL/F of PF-06372865 alone vs coadministration with itraconazole
Time frame: 0 to 120 hours post PF-06372865
CL/F (oral clearance) of PF-06372865 following single dose co-administered with itraconazole or given alone
Vz/F of PF-06372865 alone vs coadministration with itraconazole
Time frame: 0 to 120 hours post PF-06372865
Vz/F (volume distribution) of PF-06372865 following single dose co-administered with itraconazole or given alone
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 26 Jun 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06372865 and itraconazole in people with Healthy, run by Pfizer at 2 sites 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 4 inclusion and 16 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 ratio of PF-06372865 alone vs coadministration with itraconazole (time frame: 0 to 120 hours post PF-06372865). The study lists 6 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 Jun 2017.