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Topical Multiple Ascending Dose Study for PF-06423264

NCT ID: NCT02778477

Last Updated: 2017-06-21

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-23

Study Completion Date

2017-05-23

Brief Summary

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The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.

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Detailed Description

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Conditions

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Normal Healthy

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A_Cohort 1_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 1_Placebo

Multiple dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part A_Cohort 2_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 2_Placebo

Multiple dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part A_Cohort 3_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 3_Placebo

Multiple dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part A_Cohort 4_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 4_Placebo

Multiple dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part A_Cohort 5_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 5_Placebo

Multiple dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part A_Cohort 6_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 6_Placebo

Multiple dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part A_Cohort 7_Active

Multiple ascending dose of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 7_Placebo

Multiple ascending dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part B_Cohort 1_Active

Multiple doses of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part B_Cohort 1_Placebo

Multiple doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Part B_Cohort 2_Active

Multiple doses of PF-06423264

Group Type EXPERIMENTAL

PF-06423264

Intervention Type DRUG

Multiple ascending dose of PF-06423264

Part B_Cohort 2_Placebo

Multiple doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Multiple dose of placebo

Interventions

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PF-06423264

Multiple ascending dose of PF-06423264

Intervention Type DRUG

Placebo

Multiple dose of placebo

Intervention Type OTHER

Other Intervention Names

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Placebo comparator

Eligibility Criteria

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Inclusion Criteria

* Healthy males and female of non-childbearing potential;
* Body Mass Index 17.5-35.5 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 allergises, 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=B7561002&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+The+Safety%2C+Tolerability+And+Pharmacokinetics+Of+Single+And++Multiple+Ascending+Doses+Of+Pf-06423264+Administered+Topically+To+Sequential+Cohorts+Of+Healthy+Subjects

To obtain contact information for a study center near you, click here.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7561002&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+The+Safety%2C+Tolerability+And+Pharmacokinetics+Of+Multiple+Ascending+Doses+Of+Pf-06423264+Administered+Topically+To+Sequential+Cohorts+Of+Healthy+Subjects+With+And+Without+Oily+Skin

To obtain contact information for a study center near you, click here.

Other Identifiers

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2014-003736-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7561002

Identifier Type: -

Identifier Source: org_study_id

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