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Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers

NCT ID: NCT03232905

Last Updated: 2017-12-06

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2017-11-22

Brief Summary

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This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06651600

Multiple ascending doses of PF-06651600

Group Type EXPERIMENTAL

PF-06651600

Intervention Type DRUG

PF-06651600 will be administered as tablet

Placebo

Multiple ascending doses of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo will be administered as tablet

Interventions

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PF-06651600

PF-06651600 will be administered as tablet

Intervention Type DRUG

Placebo

Matching placebo will be administered as tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must have four Japanese grandparents who were born in Japan.
* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* BMI of 17.5 to 27.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
* Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Screening blood pressure \>140/90 mm Hg.
* Screening laboratory abnormalities as defined by the protocol.
* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
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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Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

Reference Type DERIVED
PMID: 37917289 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981008&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Third-party+Open%2C+Placebo-controlled+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+After+Multiple+Oral+Doses+Of+Pf-06651600+In+Healthy+Japanese+Subjects

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Other Identifiers

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2017-001298-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7981008

Identifier Type: -

Identifier Source: org_study_id