MedDataX Logo

Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845

NCT ID: NCT00856258

Last Updated: 2009-12-23

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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

To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.

Detailed Description

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

The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.

Conditions

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

Healthy Volunteers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Multiple dose in healthy volunteers

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

Cohort 1 completed.

Group Type PLACEBO_COMPARATOR

PF 03882845 and Placebo

Intervention Type DRUG

The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.

Cohort 2

Cohort 2 not studied

Group Type PLACEBO_COMPARATOR

PF 03882845 and Placebo

Intervention Type DRUG

The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.

Cohort 3

Cohort 3 not studied

Group Type PLACEBO_COMPARATOR

PF 03882845 and Placebo

Intervention Type DRUG

The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.

Cohort 4

Cohort 4 not studied

Group Type PLACEBO_COMPARATOR

PF 03882845 and Placebo

Intervention Type DRUG

The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.

Interventions

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

PF 03882845 and Placebo

The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.

Intervention Type DRUG

PF 03882845 and Placebo

The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.

Intervention Type DRUG

PF 03882845 and Placebo

The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.

Intervention Type DRUG

PF 03882845 and Placebo

The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive 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

* Healthy male and 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.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

* Evidence or history of clinically significant disease, allergy or clinical findings at screening.
* A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* Pregnant or nursing females; females of childbearing potential.
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.

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

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=B0171002&StudyName=Multiple%20dose%20study%20in%20healthy%20volunteers%20to%20assess%20safety%2C%20pharmacokinetics%20and%20pharmacodynamics%20of%20PF%2003882845

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.

B0171002

Identifier Type: -

Identifier Source: org_study_id