A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

NCT ID: NCT02286882

Last Updated: 2015-07-20

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 2: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 3: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 4: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 5: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 6: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 7: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 8: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Cohort 9: PF-06409577 or placebo

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06409577 or Placebo

Intervention Type DRUG

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Interventions

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PF-06409577 or Placebo

PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male, or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight \>50 kg

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 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

Other Identifiers

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FIH

Identifier Type: OTHER

Identifier Source: secondary_id

2014-004022-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7881001

Identifier Type: -

Identifier Source: org_study_id

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