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GDC-0973

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0973 · 1 trial · 1 indication

Phase 1 1
NCT01711762A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male VolunteersHealthy Volunteer
COMPLETED6 Analytics
PHASE1COMPLETED
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
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Study Endpoints

Primary Endpoints

Route of elimination of [14C]-GDC-0973
approximately 8 weeks
Pharmacokinetics: maximum observed concentration (Cmax)
approximately 8 weeks
Pharmacokinetics: time to maximum concentration (tmax)
approximately 8 weeks
Pharmacokinetics: area under the concentration-time curve
approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase rate constant
approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase half-life
approximately 8 weeks
Pharmacokinetics: apparent total clearance
approximately 8 weeks
Pharmacokinetics: apparent volume of distribution
approximately 8 weeks
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
approximately 8 weeks

Secondary Endpoints

Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates
approximately 8 weeks
Pharmacokinetics: plasma concentration of GDC-0973
approximately 8 weeks
Safety: incidence of adverse events
approximately 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
GDC-0973 Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0973DRUGSingle oral dose of \[14C\]-GDC-0973
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive * No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations * Negative test for selected drugs of abuse * No infection with hepatitis B, hepatitis C, human immun...

Countries:United States
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Frequently asked questions about GDC-0973

What is GDC-0973?

GDC-0973 is an investigational small molecule being developed by Roche Holding AG (ticker: RHHBY). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed clinical trial involving 6 participants.

What is GDC-0973 used for?

GDC-0973 is being studied for use in healthy volunteers. The completed Phase 1 trial was a pharmacokinetics study in healthy male volunteers. The drug is still in clinical development and is not approved for any indication.

Who makes GDC-0973?

GDC-0973 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 1 clinical trial of the drug in the United States.

What phase is GDC-0973 in?

GDC-0973 is in Phase 1 clinical development. The drug is investigational 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 GDC-0973 in?

GDC-0973 has one completed clinical trial, NCT01711762, titled "A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers." This Phase 1 study enrolled 6 healthy male participants in the United States.