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OpenTrials
Completed

NCT Number: NCT03821493

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, Be-bru, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Other names: Sporanox Oral Solution

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Incidence of treatment-emergent adverse events (AEs)

    Time frame: Baseline up to 35 days

  2. Number of adverse events leading to discontinuation

    Time frame: Baseline up to 35 days

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

    Time frame: Baseline to Day 9

  4. Number of participants with clinically significant abnormalities in clinical laboratory values

    Time frame: Baseline to Day 9

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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