Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821493
• Other study ID #: B7981023
• Secondary ID: 2018-004664-55
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2019
• Est. completion date: June 4, 2019

Study information

• Verified date: June 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 4, 2019
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

• Evidence of congestive heart failure or history of congestive heart failure or any of the following: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident including transient ischemic attack or pulmonary embolus.

• 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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels	Be-bru

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600	Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity.	0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
Primary	Maximum observed plasma concentration of PF-06651600	Peak concentration of PF-06651600	0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours
Secondary	Incidence of treatment-emergent adverse events (AEs)		Baseline up to 35 days
Secondary	Number of adverse events leading to discontinuation		Baseline up to 35 days
Secondary	Number of participants with clinically significant change in vital signs from Baseline		Baseline to Day 9
Secondary	Number of participants with clinically significant abnormalities in clinical laboratory values		Baseline to Day 9

External Links

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