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.

Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091532
• Other study ID #: A3941010
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Dose
• Pharmacokinetic
• Phase 1
• Safety
• Toleration

Intervention

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.
• placebo
given orally twice daily for 14 days
• 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.
• placebo
given orally twice daily for 14 days
• 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.
• placebo
given orally twice daily for 14 days
• 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.
• placebo
given orally, once on Days 1 & 14, and twice daily on Days 3-13.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.		14 days
Secondary	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
Secondary	Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations.		14 days

External Links

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