MedTrace Logo

A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers

NCT02066909 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2015-06-24

No results posted yet for this study

Summary

This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety/tolerability and PK data from the Western and Japanese populations.

Conditions

  • Healthy

Interventions

DRUG

0.15 mg PF-06649751

Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.

DRUG

0.5 mg PF-06649751

Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.

DRUG

0.5 mg PF-06649751

Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.

DRUG

1.5 mg PF-06649751

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.

DRUG

1.5 mg PF-06649751 21 Days

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.

DRUG

3.0 mg PF-06649751

Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.

DRUG

5.0 mg PF-06649751

Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.

DRUG

8.0 mg PF-06649751

Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.

DRUG

1.5 mg PF-06649751 in healthy Japanese subjects

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066909 on ClinicalTrials.gov