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ORIC-101

Phase 1

Undisclosed | Small molecule | Other |Oric Pharmaceuticals, Inc.|Trials Updated: Feb 8, 2019

ORIC-101 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Oct 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

ORIC-101 clinical trials

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?

ORIC-101 is an investigational small molecule developed by Oric Pharmaceuticals, Inc. It has been studied in Phase 1 clinical trials involving healthy adult volunteers. The specific disease indications being pursued for ORIC-101 have not been publicly disclosed, and the compound remains in early-stage clinical development.

Who makes ORIC-101?

ORIC-101 is being developed by Oric Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ORIC. The company sponsored both Phase 1 trials of the compound conducted to date.

What phase is ORIC-101 in?

ORIC-101 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ORIC-101 in?

ORIC-101 has been evaluated in two completed Phase 1 trials. NCT03835637 was a single and multiple dose study in 32 adult healthy subjects in the United Kingdom. NCT03324555 was a study in 24 healthy adult subjects in the United States. Together these trials enrolled 56 participants.

Were the ORIC-101 trials randomized or blinded?

The two completed Phase 1 trials of ORIC-101 were controlled studies but were not randomized and not double blinded. Both trials enrolled healthy adult volunteers, with 32 participants in NCT03835637 and 24 participants in NCT03324555, for a total enrollment of 56.