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.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01091532
First received: March 22, 2010
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Phase 1
Multiple Dose
Safety
Toleration
Pharmacokinetic
Drug: UK-396,082
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects will be assigned to receive either UK-396,082 or placebo
Drug: UK-396,082

100mg given orally twice daily for 14 days

The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.

Drug: placebo
given orally twice daily for 14 days
Experimental: Cohort 2
Subjects will be assigned to receive either UK-396,082 or placebo
Drug: UK-396,082

300mg given orally twice daily for 14 days

The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.

Drug: placebo
given orally twice daily for 14 days
Experimental: Cohort 3
Subjects will be assigned to receive either UK-396,082 or placebo
Drug: UK-396,082

1000mg given orally twice daily for 14 days

The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.

Drug: placebo
given orally twice daily for 14 days
Experimental: Cohort 4
Subjects will be assigned to receive either UK-396,082 or placebo
Drug: UK-396,082

UK-396,082 given orally, once on Days 1 & 14, and twice daily on Days 3-13.

The decision to proceed to the next higher dose will be made jointly by the Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts. Dependent on the emerging safety, tolerability and PK data, Cohort 4 may be recruited to study a higher (or lower) dose of UK-396,082 in order to characterize further the safety, toleration and PK and/or to define the maximum tolerated dose. The dose in Cohort 4 will be selected such that the predicted Cmax will not exceed 46 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose.

Drug: placebo
given orally, once on Days 1 & 14, and twice daily on Days 3-13.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091532

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01091532     History of Changes
Other Study ID Numbers: A3941010
Study First Received: March 22, 2010
Last Updated: July 27, 2010
Health Authority: FAMHP: Federal Agency for Medicines and Health Products, Belgium

ClinicalTrials.gov processed this record on July 26, 2014