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GDC-3280

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Mar 17, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

GDC-3280 · 1 trial · 1 indication

Phase 1 1
NCT02471859A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy ParticipantsHealthy Volunteer
COMPLETED8 Analytics
PHASE1COMPLETED
A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of participants experiencing an adverse event
Up to approximately 6 months

Secondary Endpoints

Maximum concentration (Cmax) for GDC-3280
Up to 4 days
Time to Cmax (Tmax) for GDC-3280
Up to 4 days
Total serum clearance for GDC-3280
Up to 4 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: GDC-3280EXPERIMENTALParticipants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.
Part A: PlaceboPLACEBO_COMPARATORParticipants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
Part B: GCD-3280EXPERIMENTALParticipants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\\n
Part B: PlaceboPLACEBO_COMPARATORParticipants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\\n

Interventions

NameTypeDescription
GDC-3280DRUGGDC-3280 at various doses, depending on the cohort and treatment period
PlaceboDRUGPlacebo at various doses, depending on the cohort and treatment period
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is male or female, using highly effective contraception * Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive * Is in good general health * Having signed informed consent, is willing and able to comply with requirements of the study Exclusion Criteria: * Does not satis...

Countries:United Kingdom
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Frequently asked questions about GDC-3280

What is GDC-3280?

GDC-3280 is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and the only completed trial was a safety, tolerability, and pharmacokinetic study.

What is GDC-3280 used for?

GDC-3280 is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The completed trial focused on assessing its safety, tolerability, and pharmacokinetics in healthy participants.

Who makes GDC-3280?

GDC-3280 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.

What phase is GDC-3280 in?

GDC-3280 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The only trial conducted was a Phase 1 study in healthy volunteers, which has been completed.

What clinical trials is GDC-3280 in?

GDC-3280 has one completed clinical trial, NCT02471859, titled "A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants." This Phase 1 study enrolled 8 participants in the United Kingdom and was placebo-controlled, randomized, and double-blind.