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A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

NCT ID: NCT02391623

Last Updated: 2016-03-02

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

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PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult 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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Cohort 1

Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Placebo

Intervention Type DRUG

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Cohort 2

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Placebo

Intervention Type DRUG

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Cohort 3

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Placebo

Intervention Type DRUG

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Cohort 4

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Placebo

Intervention Type DRUG

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Cohort 5

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Placebo

Intervention Type DRUG

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Cohort 6

Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).

Placebo

Intervention Type DRUG

Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).

Interventions

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PF-06427878

PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Intervention Type DRUG

Placebo

Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Intervention Type DRUG

PF-06427878

PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).

Intervention Type DRUG

Placebo

Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects of non childbearing potential.
* Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight \>50 kg
* Subjects with fasting TG level of \>=90 mg/dL and \<=500 mg/dL following an overnight fast
* Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

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

References

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Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520):eaav9701. doi: 10.1126/scitranslmed.aav9701.

Reference Type DERIVED
PMID: 31776293 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7871002&StudyName=A%20Phase%201%2C%20Randomized%2C%20Double-blind%2C%20Placebo-controlled%20Study%20To%20Assess%20The%20Safety%2C%20Tolerability%2C%20And%20Pharmacokinetics%20Of%20Multiple%20Escalating%20Oral%20Doses%20Of%20Pf-06427878%20Co%20Administered%20With%20And%20Without%20Food%20In%20Healthy%20Adult%20Subjects

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

Other Identifiers

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2015-000130-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7871002

Identifier Type: -

Identifier Source: org_study_id

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