Recent Updates
Recently added Catalysts

UK-396, 082

Phase 1

Phase 1 | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 4, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

UK-396, 082 · 1 trial · 5 indications

Phase 1 1
NCT01091532A 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
COMPLETED48 Analytics
PHASE1COMPLETED
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 1Unlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSubjects will be assigned to receive either UK-396,082 or placebo
Cohort 2EXPERIMENTALSubjects will be assigned to receive either UK-396,082 or placebo
Cohort 3EXPERIMENTALSubjects will be assigned to receive either UK-396,082 or placebo
Cohort 4EXPERIMENTALSubjects will be assigned to receive either UK-396,082 or placebo

Interventions

NameTypeDescription
UK-396,082DRUG100mg 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.
placeboDRUGgiven orally twice daily for 14 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Belgium
Unlock Eligibility Criteria

Frequently asked questions about UK-396, 082

What is UK-396,082?

UK-396,082 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to assess its safety, toleration, and pharmacokinetics.

What is UK-396,082 used for?

UK-396,082 is being investigated for use in a Phase 1 setting. The completed clinical trial focused on evaluating the safety, toleration, and time course of blood concentration of the drug after multiple oral doses in healthy people. Its specific therapeutic indication has not been established.

Who makes UK-396,082?

UK-396,082 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company conducted a Phase 1 clinical trial of the drug in healthy volunteers.

What phase is UK-396,082 in?

UK-396,082 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is UK-396,082 in?

UK-396,082 has one completed clinical trial registered as NCT01091532. This Phase 1 study enrolled 48 healthy participants in Belgium and evaluated the safety, toleration, and pharmacokinetics of multiple oral doses of the drug. The trial was randomized, double-blind, and controlled.

Is UK-396,082 the same as any other drug?

No alternative names for UK-396,082 have been reported. The drug is identified by its code name UK-396,082 in clinical trial registrations and is developed by Pfizer, Inc.