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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Single Ascending Dose Cross-over

Single Ascending Dose in 4-way cross-over design (PF-06751979/Placebo).

Group Type EXPERIMENTAL

PF-06751979 single ascending dose

Intervention Type DRUG

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.

Placebo single dose

Intervention Type DRUG

Matched Placebo solution/suspension administered as single dose.

Multiple Ascending Dose PF-06751979

Multiple dose administration to Healthy Subjects in parallel cohorts(PF-06751979)

Group Type EXPERIMENTAL

PF-06751979 multiple ascending dose

Intervention Type DRUG

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

Multiple Ascending Dose Placebo

Multiple dose administration to Healthy Subjects in parallel cohorts(Placebo)

Group Type PLACEBO_COMPARATOR

Placebo multiple dose

Intervention Type DRUG

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

PF-06751979 multiple dose

Intervention Type DRUG

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

Multiple Dose Elderly PF-06751979

Multiple dose administration to Healthy Elderly Subjects (PF-06751979)

Group Type EXPERIMENTAL

PF-06751979 multiple dose

Intervention Type DRUG

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

Multiple Dose Elderly Placebo

Multiple dose administration to Healthy Elderly Subjects (Placebo)

Group Type PLACEBO_COMPARATOR

Placebo multiple dose

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo single dose

Matched Placebo solution/suspension administered as single dose.

Intervention Type 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.

Intervention Type DRUG

Placebo multiple dose

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

Intervention Type DRUG

PF-06751979 multiple dose

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

Intervention Type DRUG

PF-06751979 multiple dose

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years or between the ages of 60 and 85 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lbs) at Screening.
* Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.

Exclusion Criteria

* 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 the time of dosing).
* Male subjects with partners currently pregnant; male subjects able to father children 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 after the last dose of investigational product.
* Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
* Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
* Any severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes