An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults.

NCT02883114 | Completed Phase 1

• 1 other identifier: B7991006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single dose administration in healthy subject.

Conditions

Healthy

Keywords

PF-06648671; GSM; CYP3A; drug interaction

Outcome Measures

Primary Outcomes (7)

• Maximum Observed PF-06648671 Plasma Concentration (Cmax)

  Camx after single dose of 25 mg PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2 following single dose PF-06648671

• Time to Reach Maximum Observed Plasma concentration (Tmax)

  Tmax following single doses of PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2

• Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)

  AUCinf following single doses of PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2

• Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)

  AUClast following single doses of PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2

• Plasma Decay Half-life (t1/2)

  t1/2 following single doses of PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2

• Apparent Oral Clearance (CL/F)

  CL/F following single doses of PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2

• Apparent Volume of Distribution (Vz/F)

  Vz/F following single doses of PF-06648671 in period 1 and period 2

  0-48 hours in period 1 and 0-240 hours in period 2

Study Arms (1)

single cohort

EXPERIMENTAL

single dose of PF-06648671 in period 1 and 14-day dose of itraconazole plus single dose of PF-06648671 in period 2

Drug: PF-06648671; Drug: Itraconazole

Interventions

PF-06648671 DRUG

Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2.

single cohort

Itraconazole DRUG

Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2

single cohort

Eligibility Criteria

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

You may qualify if:

• Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years at the time of screening, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Hypersensitivity or previous adverse events due to azole antifungals.
• A positive urine drug testing.
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of Screening.
• Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication, whichever is longer.
• Screening supine blood pressure \>=140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is \>=140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
• Screening supine 12 lead ECG demonstrating corrected QT (QTc) \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
• Subjects with ANY of the following abnormalities in clinical laboratory tests at Screening AND at Day 0, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary:
• Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>1x upper limit of normal (ULN);
• Total bilirubin\>=1.5 x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ULN.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days, or longer based upon the compound's half life characteristics, after the last dose of investigational product.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
• History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV). As an exception, a positive HBsAb finding as a result of subject vaccination is permissible.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

US (1)