MedDataX Logo

Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

NCT ID: NCT00959803

Last Updated: 2009-12-07

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

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 investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.

Related Clinical Trials

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

A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

NCT03597217

Healthy
COMPLETED PHASE1

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated

NCT05183347

Healthy
COMPLETED PHASE1

Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects

NCT01217918

Healthy
COMPLETED PHASE1

A Study of JNJ-61393215 in Healthy Japanese Male Participants

NCT04713930

Healthy
COMPLETED PHASE1

Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants

NCT04444050

Healthy Participants
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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Single dose

3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

3 mg solution, oral single dose.

PF-04447943

Intervention Type DRUG

10 mg solution, oral single dose.

PF-04447943

Intervention Type DRUG

25 mg solution, oral single dose.

Placebo

Intervention Type DRUG

Solution, oral single dose.

Multiple dose

3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

25 mg solution, oral twice daily for 7 days.

Placebo

Intervention Type DRUG

Solution, oral twice daily for 7 days.

Interventions

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

PF-04447943

3 mg solution, oral single dose.

Intervention Type DRUG

PF-04447943

10 mg solution, oral single dose.

Intervention Type DRUG

PF-04447943

25 mg solution, oral single dose.

Intervention Type DRUG

Placebo

Solution, oral single dose.

Intervention Type DRUG

PF-04447943

25 mg solution, oral twice daily for 7 days.

Intervention Type DRUG

Placebo

Solution, oral twice daily for 7 days.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive.
* For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.
* Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Pregnant or nursing women; women of childbearing potential.
* Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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.

Pfizer, Inc.

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.

Pfizer Investigational Site

Glendale, California, 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=B0401004&StudyName=Study%20Of%20Single%20Ascending%20And%20Multiple%20Doses%20Of%20PF-04447943%20In%20Japanese%20Subjects.

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.

B0401004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses
NCT01199315 COMPLETED PHASE1
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject
NCT01021189 COMPLETED PHASE1
Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants
NCT04863417 COMPLETED PHASE1
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.
NCT00799747 COMPLETED PHASE1
A Study of JNJ-40411813 in Healthy Japanese Male Participants
NCT04677530 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
NCT01505894 COMPLETED PHASE1
A Study of JNJ-67953964 in Healthy Japanese Adult Male Participants
NCT04791332 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
NCT03188783 COMPLETED PHASE1
Study Evaluating IMA-638 in Healthy Japanese
NCT00340327 COMPLETED PHASE1
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects
NCT00972049 COMPLETED PHASE1
A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants
NCT06368440 COMPLETED PHASE1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-99677 in Healthy Adult Japanese Participants.
NCT04958291 COMPLETED PHASE1
Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069
NCT01100047 COMPLETED PHASE1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants
NCT02933580 COMPLETED PHASE1
AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects
NCT00935025 TERMINATED PHASE1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants
NCT01631487 COMPLETED PHASE1
Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
NCT04451083 COMPLETED PHASE1
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants
NCT04628793 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants
NCT04461483 COMPLETED PHASE1
Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..
NCT05955183 COMPLETED PHASE1
AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects
NCT01114152 COMPLETED PHASE1
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers
NCT01233830 COMPLETED PHASE1
A Study of JNJ-64530440 in Healthy Japanese Male Participants
NCT03915886 TERMINATED PHASE1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants
NCT02398591 COMPLETED PHASE1
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 1015550 Are Taken up in the Body and How Well They Are Tolerated.
NCT03542344 COMPLETED PHASE1