Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects

Oric Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ORIC-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03835637

ORIC-GR-17002

Details and patient eligibility

About

This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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) in a clinical research study within the previous 3 months
• History of any drug or alcohol abuse in the past 2 years
• Current smokers and those who have smoked within the last 12 months
• Females of childbearing potential
• Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
• Current disease requiring treatment with systemic corticosteroids
• Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 7 patient groups

Regimen A

Experimental group

Treatment:

Drug: ORIC-101

Regimen B

Experimental group

Treatment:

Drug: ORIC-101

Regimen C

Experimental group

Treatment:

Drug: ORIC-101

Regimen D

Experimental group

Treatment:

Drug: ORIC-101

Regimen F

Experimental group

Treatment:

Drug: ORIC-101

Regimen H

Experimental group

Treatment:

Drug: ORIC-101

Regimen I

Experimental group

Treatment:

Drug: ORIC-101