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ORIC-101

Phase 1

Healthy Volunteers | Small molecule | Other |Oric Pharmaceuticals, Inc.|Last Updated: Feb 8, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

ORIC-101 · 2 trials · 1 indication

Phase 1 2
NCT03835637Single and Multiple Dose Study of ORIC-101 in Adult Healthy SubjectsHealthy Volunteers
COMPLETED32 Analytics
NCT03324555Study of ORIC-101 in Healthy Adult SubjectsHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Study of ORIC-101 in Healthy Adult Subjects
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum plasma concentration (Cmax)
96 hours post-final dose

PK of ORIC-101 as single doses

Area under the curve (AUC)
96 hours post-final dose

PK of ORIC-101 as single doses

Number of participants with adverse events
96 hours post-final dose

Safety and tolerability of ORIC-101 as single doses

Number of Participants With Abnormal Laboratory Values
96 hours post-final dose

Safety and tolerability of ORIC-101 as single doses

Safety and tolerability, as assessed by incidence and severity of adverse events.
96 hours post-dose

Secondary Endpoints

Maximum plasma concentration (Cmax)
96 hours post-final dose
Area under the curve (AUC)
96 hours post-final dose
Number of participants with adverse events
96 hours post-final dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Regimen AEXPERIMENTAL -
Regimen BEXPERIMENTAL -
Regimen CEXPERIMENTAL -
Regimen DEXPERIMENTAL -
Regimen FEXPERIMENTAL -
Regimen HEXPERIMENTAL -
Regimen IEXPERIMENTAL -
ORIC-101EXPERIMENTAL -

Interventions

NameTypeDescription
ORIC-101DRUGCapsule or oral suspension
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or healthy females of non-child bearing potential * Age 18 to 65 years of age * Body mass index of 18.0 to 32.0 kg/m\^2 and weight between 50 kg and 120 kg, inclusive Exclusion Criteria: * Subjects who have received any investigational medicinal product (IMP) i...

Countries:United KingdomUnited States
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Frequently asked questions about ORIC-101

What is ORIC-101 used for?

ORIC-101 is an investigational small molecule being studied in healthy volunteers. It is in Phase 1 clinical development, with two completed trials in the United States and the United Kingdom. The drug is not approved and remains under investigation.

Who makes ORIC-101?

ORIC-101 is being developed by Oric Pharmaceuticals, Inc., a biopharmaceutical company traded under the ticker ORIC. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy adult subjects.

What phase is ORIC-101 in?

ORIC-101 is in Phase 1 clinical development. Two Phase 1 trials in healthy volunteers have been completed, one in the United States and one in the United Kingdom. The drug is investigational and has not been approved.

What clinical trials is ORIC-101 in?

ORIC-101 has been studied in two completed Phase 1 trials. NCT03324555 enrolled 24 healthy adults in the United States, and NCT03835637 enrolled 32 healthy adults in the United Kingdom. Both trials were controlled and open-label.

Is ORIC-101 FDA approved?

ORIC-101 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development, studied only in healthy volunteers. Both of its clinical trials have been completed, but the drug remains unapproved and under investigation.