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First in Human Study for PF-06667272

NCT ID: NCT03126149

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2017-09-05

Brief Summary

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The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1_Period 1_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 1_Period 1_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohort 1_Period 2_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 1_Period 2_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohort 1_Period 3_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 1_Period 3_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohrot 1_Period 4_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 1_Period 4_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohort 2_Period 1_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 2_Period 1_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohort 2_Period 2_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 2_Period 2_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohort 2_Period 3_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 2_Period 3_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Cohort 2_Period 4_Active

Single ascending dose of PF-06667272

Group Type EXPERIMENTAL

PF-06667272

Intervention Type DRUG

Single ascending dose of PF-06667272

Cohort 2_Period 4_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo

Interventions

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PF-06667272

Single ascending dose of PF-06667272

Intervention Type DRUG

Placebo

Single dose of placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy males and female of non-childbearing potential;
* Body Mass Index 17.5-30.5 kg/m2;
* Body weight \>50 kg;

Exclusion Criteria

* Evidence of 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 time of dosing)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C0231002&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind+%28sponsor-open%29%2C+Placebo-controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Single+Escalating+Oral+Doses+Of+Pf-06667272+Under+Fed+And+Fasted+Conditions%2C+In+Healthy+Adult+Subjects

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Other Identifiers

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2017-000590-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C0231002

Identifier Type: -

Identifier Source: org_study_id