A Study To Estimate The Effects Of Itraconazole On Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects

NCT03121664 | Completed Phase 1 FDA Drug

• 2 other identifiers: B76010062016-005201-39
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy subjects

Conditions

Healthy

Keywords

Drug drug interaction, CYP3A4, itraconazole

Outcome Measures

Primary Outcomes (2)

• PF-06649751 and PF-06752844 steady state Cmax

  Maximum Observed Plasma Concentration

  Day 11 and Day 25

• PF-06649751 and PF-06752844 steady state AUC24

  Area Under the Curve From Time Zero to the end of the dosing period

  Days 11 and Day 25

Secondary Outcomes (6)

• Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Day 0

• Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Day 7

• Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Day 14

• Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Day 21

• Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Day 26

Study Arms (1)

Cohort 1

EXPERIMENTAL

Drug: PF06649751, Itraconazole

Interventions

PF06649751, Itraconazole DRUG

PF-06649751 0.25 mg on Days 1,2,3 PF-06649751 0.5 mg on Days 4,5,6 PF-06649751 1 mg on Days 7 to Day 25 Itracoanzole 200 mg on Days 12 to Day 25

Cohort 1

Eligibility Criteria

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

You may qualify if:

• Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
• Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
• 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, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
• Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
• Unwilling or unable to comply with the Lifestyle Requirements described in this protocol
• Subjects who had a history of allergy or intolerance to azole antifungal drugs

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• 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
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 20, 2017
• Study Start: April 7, 2017
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)