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

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

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

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

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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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