A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin

Summary

This is a Phase 1, single-dose, randomized, 3-treatment, 3-period cross-over, sponsor-open, placebo-and positive-controlled trial to be conducted in approximately 36 adult healthy volunteers. There will be 3 crossover treatments: PF-04965842 600 mg (A), placebo (B) and moxifloxacin 400 mg (C). Treatment assignments to PF-04965842 and placebo will be blinded to the subjects, investigator and Clinical Research Unit (CRU) staff (except pharmacist) but open to the sponsor. Moxifloxacin administration will be unblinded. Dosing in each of the 3 treatment periods will be separated by a washout period of at least 5 days

Screening evaluation will occur within the 28 days prior to dosing in the first treatment period. During each treatment period, eligible subjects who meet the entry criteria will be admitted on Day -1, prior to treatment administration on Day 1, and will reside in the CRU until completion of protocol assessments on Day 2. There will be a washout of at least 5 days between dose administrations in consecutive crossover treatment periods. After completion of the 3 study periods or upon withdrawal from the study, subjects will return for a follow-up visit approximately 7-14 days following last dose of investigational product. Further follow-up contact will be made at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product to capture any potential AEs and concomitant treatments, and to confirm appropriate contraception usage, contact with the subject may be done via phone. For each subject, the duration of participation from Day 1 admission to follow-up visit will be approximately 10 weeks. The follow-up call will occur up to 4 weeks after the follow-up visit.

In each treatment period, the subject will be admitted to the CRU the day prior to dosing. Genotyping samples for CYP2C19 and CYP2C9 will be collected pre-dose in Period 1 only. The subject will receive a single dose of the assigned trial medication in the morning of Day 1. Triplicate 12-lead ECG measurements (approximately 2 minutes apart) will be performed on Days 1 and 2 of each treatment period as follows: -1, -0.5 and 0 hours pre-dose and at 0.25, 0.5, 1, 2, 3, 6, 12, and 24 hours post-dose. Blood samples will be collected following the 0 hour and post-dose ECG measurements at the same time-points to evaluate the PK of PF-04965842 and moxifloxacin (if needed). Clinical safety laboratory tests will be performed on Day -1 and at 24 hours on Day 2, and vital signs (supine pulse rate and BP) will be monitored pre-dose and at 2 and 6 hours post-dose on Day 1 and at 24 hours on Day 2. The subject will be discharged from the CRU after completing all trial procedures of the particular treatment period in the morning of Day 2 (24 hours post-dose).

Conditions

• Healthy Volunteers

Interventions

DRUG

PF-04965842

one single dose of 600 mg by mouth

DRUG

Moxifloxacin

one single dose of 400 mg by mouth

DRUG

Placebo

one single dose by mouth

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-07-02

Primary Completion

2018-10-01

Completion

2018-10-01

FDA Drug

Yes

Countries

• Belgium

Study Locations