Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants
NCT ID: NCT03821493
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2019-02-21
2019-06-04
Brief Summary
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This is an open-label, fixed sequence two period study with healthy participants that will receive a single dose of PF-06651600 alone and co-administered with multiple doses of itraconazole at a single center.
Participants will be screened within 28 days of the first dose of the investigational products and if entry criteria are met, the participant will report to the clinic on the day before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive 30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The participant will be followed up by phone contact.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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PF-06651600 treatment arm
This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole
PF-06651600 10 mg tablets
On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.
On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.
Itraconazole Solution 200 mg
Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.
On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.
Interventions
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PF-06651600 10 mg tablets
On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.
On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole.
Itraconazole Solution 200 mg
Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.
On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.
Exclusion Criteria
* Known hypersensitivity to itraconazole or it excipients or to other azole antifungals.
* Infection with Hepatitis B, C or HIV
* Known present or history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Clinical Research Unit
Brussels, Be-bru, Belgium
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-004664-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7981023
Identifier Type: -
Identifier Source: org_study_id