A Double Blind, Randomized 3rd Party Open, Placebo Controlled, Parallel Group Multiple Oral Escalating Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UK-396,082 In Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cohort 1
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: UK-396,082 (Drug)
Cohort 1
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: placebo (Drug)
Cohort 2
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: UK-396,082 (Drug)
Cohort 2
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: placebo (Drug)
Cohort 3
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: UK-396,082 (Drug)
Cohort 3
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: placebo (Drug)
Cohort 4
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: UK-396,082 (Drug)
Cohort 4
Subjects will be assigned to receive either UK-396,082 or placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
Time Frame: 14 days
Secondary Outcomes
- 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)