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.

Phase 1

Completed

• Conditions: Pharmacokinetic; Phase 1; Multiple Dose; Safety; Toleration
• Interventions: Drug: UK-396,082; Drug: placebo

• Registration Number: NCT01091532
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-24
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4	placebo	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 2	placebo	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 1	placebo	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 3	placebo	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 3	UK-396,082	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 4	UK-396,082	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 1	UK-396,082	Subjects will be assigned to receive either UK-396,082 or placebo
Cohort 2	UK-396,082	Subjects will be assigned to receive either UK-396,082 or placebo

Primary Outcome Measures

Name	Time	Method
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.	14 days

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, Rac (=AUCtau (Day 14)/AUCtau (Day 1)), CL/F, Vz/f, Cmin, Cav Urine pharmacokinetics: Aetau & Aetau%, CLR on Day 14	14 days
Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations.	14 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium