Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants
|ClinicalTrials.gov Identifier: NCT03821493|
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : June 28, 2019
This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Participants||Drug: PF-06651600 10 mg tablets Drug: Itraconazole Solution 200 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06651600 IN HEALTHY PARTICIPANTS|
|Actual Study Start Date :||February 21, 2019|
|Actual Primary Completion Date :||April 6, 2019|
|Actual Study Completion Date :||June 4, 2019|
Experimental: 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
Drug: 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.
Drug: 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 Name: Sporanox Oral Solution
- Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours ]Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity.
- Maximum observed plasma concentration of PF-06651600 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours ]Peak concentration of PF-06651600
- Incidence of treatment-emergent adverse events (AEs) [ Time Frame: Baseline up to 35 days ]
- Number of adverse events leading to discontinuation [ Time Frame: Baseline up to 35 days ]
- Number of participants with clinically significant change in vital signs from Baseline [ Time Frame: Baseline to Day 9 ]
- Number of participants with clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline to Day 9 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821493
|Pfizer Clinical Research Unit|
|Brussels, Be-bru, Belgium, B-1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|