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.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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. 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. 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. 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. 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 |
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 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 May 19, 2013