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GLYX-13

Phase 1

Healthy | Small molecule | Other |AbbVie Inc.|Last Updated: Feb 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

GLYX-13 · 1 trial · 1 indication

Phase 1 1
NCT01014650Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal VolunteersHealthy
COMPLETED53 Analytics
PHASE1COMPLETED
Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers
Healthy
NCT0101465053
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Study Endpoints

Primary Endpoints

Observed and laboratory-confirmed safety
four weeks

Secondary Endpoints

Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects.
24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IV normal salinePLACEBO_COMPARATORSingle IV dose of normal saline as a control for safety and tolerability observations
IV GLYX-13EXPERIMENTALSingle IV dose of GLYX-13
SC GLYX-13EXPERIMENTALSingle SC dose

Interventions

NameTypeDescription
GLYX-13DRUGsingle IV or SC dose
IV normal salineDRUGSingle IV dose of normal saline
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * clinical laboratory values \< 2x the upper limit of normal * ability to understand the requirements of the study and provide informed consent Exclusion Criteria: * alcohol abuse * abuse of illicit substances * current smoker * currently taking prescription medications (other...

Countries:United States
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