A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Multiple Dose; Pharmacokinetic; Phase 1; Toleration; Safety

Treatments: Drug: placebo; Drug: UK-396,082

Study type: Interventional

Funder types: Industry

Identifiers

NCT01091532

A3941010

Details and patient eligibility

About

The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given twice daily by mouth for 14 days.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects. (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).

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 time of dosing).
• A positive urine drug screen.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Subjects will be assigned to receive either UK-396,082 or placebo

Treatment:

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: UK-396,082

Cohort 2

Experimental group

Description:

Subjects will be assigned to receive either UK-396,082 or placebo

Treatment:

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: UK-396,082

Cohort 3

Experimental group

Description:

Subjects will be assigned to receive either UK-396,082 or placebo

Treatment:

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: UK-396,082

Cohort 4

Experimental group

Description:

Subjects will be assigned to receive either UK-396,082 or placebo

Treatment:

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: placebo

Drug: placebo

Drug: UK-396,082

Drug: UK-396,082