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Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

NCT ID: NCT01247896

Last Updated: 2011-07-06

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Group Type EXPERIMENTAL

PF-05190457

Intervention Type DRUG

Single Dose 2 mg

PF-05190457

Intervention Type DRUG

Single Dose 10 mg

PF-05190457

Intervention Type DRUG

Single Dose 30 mg

PF-05190457

Intervention Type DRUG

Single Dose 100 mg

PF-05190457

Intervention Type DRUG

Single Dose 300 mg

PF-05190457

Intervention Type DRUG

Single Dose 600 mg

PF-05190457

Intervention Type DRUG

Single Dose - to be determined with food

PF-05190457

Intervention Type DRUG

Single Dose - to be determined

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single Dose Placebo

Interventions

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PF-05190457

Single Dose 2 mg

Intervention Type DRUG

PF-05190457

Single Dose 10 mg

Intervention Type DRUG

PF-05190457

Single Dose 30 mg

Intervention Type DRUG

PF-05190457

Single Dose 100 mg

Intervention Type DRUG

PF-05190457

Single Dose 300 mg

Intervention Type DRUG

PF-05190457

Single Dose 600 mg

Intervention Type DRUG

PF-05190457

Single Dose - to be determined with food

Intervention Type DRUG

PF-05190457

Single Dose - to be determined

Intervention Type DRUG

Placebo

Single Dose Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of 17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220 lb) inclusive

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
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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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Cobbina E, Lee MR, Leggio L, Akhlaghi F. A Population Pharmacokinetic Analysis of PF-5190457, a Novel Ghrelin Receptor Inverse Agonist in Healthy Volunteers and in Heavy Alcohol Drinkers. Clin Pharmacokinet. 2021 Apr;60(4):471-484. doi: 10.1007/s40262-020-00942-7. Epub 2020 Nov 5.

Reference Type DERIVED
PMID: 33155163 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3301001&StudyName=Single%20Dose%20Escalation%20Study%20of%20PF-05190457%20in%20Healthy%20Volunteers

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

Other Identifiers

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B3301001

Identifier Type: -

Identifier Source: org_study_id

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