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First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979

NCT02509117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-11-01

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979 following oral doses in healthy adult and healthy elderly subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

PF-06751979 single ascending dose

PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979). The dose levels are 3 mg, 12 mg, 40 mg, 160 mg.

DRUG

Placebo single dose

Matched Placebo solution/suspension administered as single dose.

DRUG

PF-06751979 multiple ascending dose

PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts. The dose levels are 5 mg, 15 mg, 50 mg.

DRUG

Placebo multiple dose

Matched Placebo (solution/suspension)administered daily for 14 consecutive days.

DRUG

PF-06751979 multiple dose

PF-06751979 (solution/suspension) administered daily for 14 consecutive days. The dose level is 50 mg.

DRUG

PF-06751979 multiple dose

Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02509117 on ClinicalTrials.gov