MedDataX Logo

A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers

NCT ID: NCT02066909

Last Updated: 2015-06-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety/tolerability and PK data from the Western and Japanese populations.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

NCT01959594

Healthy
COMPLETED PHASE1

Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Oral Pf-06650833 In Healthy Subjects

NCT02485769

Healthy
COMPLETED PHASE1

Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

NCT02766621

Healthy
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

NCT03351751

Healthy Volunteers
COMPLETED PHASE1

A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751

NCT01981694

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

0.15 mg PF-06649751

Intervention Type DRUG

Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.

Cohort 2

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

0.5 mg PF-06649751

Intervention Type DRUG

Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.

Cohort 3

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

0.5 mg PF-06649751

Intervention Type DRUG

Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.

Cohort 4

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

1.5 mg PF-06649751

Intervention Type DRUG

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.

Cohort 5

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

1.5 mg PF-06649751 21 Days

Intervention Type DRUG

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.

Cohort 6

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

3.0 mg PF-06649751

Intervention Type DRUG

Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.

Cohort 7

Dosing in healthy Western subjects.

Group Type EXPERIMENTAL

5.0 mg PF-06649751

Intervention Type DRUG

Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.

Optional Cohort 8

Dosing in healthy Western subjects. Cohort may not be conducted.

Group Type EXPERIMENTAL

8.0 mg PF-06649751

Intervention Type DRUG

Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.

Cohort 9

Dosing in healthy Japanese subjects.

Group Type EXPERIMENTAL

1.5 mg PF-06649751 in healthy Japanese subjects

Intervention Type DRUG

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.15 mg PF-06649751

Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.

Intervention Type DRUG

0.5 mg PF-06649751

Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.

Intervention Type DRUG

0.5 mg PF-06649751

Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.

Intervention Type DRUG

1.5 mg PF-06649751

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.

Intervention Type DRUG

1.5 mg PF-06649751 21 Days

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.

Intervention Type DRUG

3.0 mg PF-06649751

Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.

Intervention Type DRUG

5.0 mg PF-06649751

Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.

Intervention Type DRUG

8.0 mg PF-06649751

Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.

Intervention Type DRUG

1.5 mg PF-06649751 in healthy Japanese subjects

Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy males and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.

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 the time of dosing).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7601002&StudyName=A%20Study%20To%20Observe%20Safety%20And%20Blood%20Concentrations%20Of%20PF-06649751%20During%20And%20Following%20The%20Oral%20Administration%20Of%20Multiple%20Doses%20Of%20PF

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-003776-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7601002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects
NCT01140672 COMPLETED PHASE1
Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
NCT01753791 COMPLETED PHASE1
A Single Dose Study Of PF-06291874 In Healthy Adult Subjects
NCT01499017 TERMINATED PHASE1
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
NCT02151617 COMPLETED PHASE1
A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
NCT02184429 COMPLETED PHASE1
A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
NCT01691274 COMPLETED PHASE1
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
NCT02201511 COMPLETED PHASE1
Safety and Tolerability Study of Multiple Doses of PF-06305591
NCT01776619 COMPLETED PHASE1
A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth
NCT00989391 COMPLETED PHASE1
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
NCT01934738 COMPLETED PHASE1
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects
NCT02539550 COMPLETED PHASE1
A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.
NCT01169714 COMPLETED PHASE1
Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects
NCT01794364 COMPLETED PHASE1
A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects
NCT02316756 COMPLETED PHASE1
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562
NCT01914796 COMPLETED PHASE1
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
NCT03146065 COMPLETED PHASE1
A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
NCT00875628 TERMINATED PHASE1
A Study to Learn How Different Amounts and Forms of the Study Medicine Called PF-06414300 Act in Healthy Adults
NCT06659250 COMPLETED PHASE1
A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
NCT03230383 COMPLETED PHASE1
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
NCT05431153 COMPLETED PHASE1
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
NCT01250730 COMPLETED PHASE1
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers
NCT00797342 COMPLETED PHASE1
Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions
NCT02224651 COMPLETED PHASE1
A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
NCT02070289 COMPLETED PHASE1
First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979
NCT02509117 COMPLETED PHASE1