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

NCT03821493 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79810232018-004664-55
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

PF-06651600; Itraconazole; CYP3A4; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Incidence of treatment-emergent adverse events (AEs)

  Baseline up to 35 days

• Number of adverse events leading to discontinuation

  Baseline up to 35 days

• Number of participants with clinically significant change in vital signs from Baseline

  Baseline to Day 9

• Number of participants with clinically significant abnormalities in clinical laboratory values

  Baseline to Day 9

Study Arms (1)

PF-06651600 treatment arm

EXPERIMENTAL

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; Drug: Itraconazole Solution 200 mg

Interventions

PF-06651600 10 mg tablets DRUG

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.

PF-06651600 treatment arm

Itraconazole Solution 200 mg DRUG

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.

Also known as: Sporanox Oral Solution

PF-06651600 treatment arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, Be-bru, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06651600; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 29, 2019
• Study Start: February 21, 2019
• Primary Completion: April 6, 2019
• Study Completion: June 4, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)