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GDC-3280

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Mar 17, 2016

GDC-3280 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2015

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

GDC-3280 clinical trials

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
Healthy VolunteerUnlock trial analytics

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 developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United Kingdom. The specific disease indications for GDC-3280 have not been disclosed.

Who makes GDC-3280?

GDC-3280 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche conducted the Phase 1 study of GDC-3280 in healthy participants.

What phase is GDC-3280 in?

GDC-3280 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 8 healthy volunteers and was conducted in the United Kingdom.

What clinical trials is GDC-3280 in?

GDC-3280 has been evaluated in one clinical trial, NCT02471859, titled A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants. The Phase 1 trial was completed, enrolled 8 participants, and was conducted in the United Kingdom.

Is GDC-3280 FDA approved?

GDC-3280 is not approved. It is an investigational small molecule in Phase 1 clinical development, and the only listed trial, NCT02471859, has been completed. No regulatory approval has been granted for GDC-3280.

What was the design of the GDC-3280 Phase 1 trial?

The GDC-3280 Phase 1 trial, NCT02471859, was a randomized, double-blind, placebo-controlled study in healthy volunteers. It enrolled 8 participants aged 18 years and older of all sexes in the United Kingdom, and assessed safety, tolerability, and pharmacokinetics.