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ORIC-101

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03835637Single and Multiple Dose Study of ORIC-101 in Adult Healthy SubjectsPHASE1 COMPLETED 32 — — Mar 23, 2018Jul 4, 2018Feb 8, 20191 United Kingdom
NCT03324555Study of ORIC-101 in Healthy Adult SubjectsPHASE1 COMPLETED 24 — — Oct 19, 2017Dec 18, 2017Apr 5, 20181 United States
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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 — 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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