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

NCT ID: NCT03835637

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2018-07-04

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Regimen A

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Regimen B

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Regimen C

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Regimen D

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Regimen F

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Regimen H

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Regimen I

Group Type EXPERIMENTAL

ORIC-101

Intervention Type DRUG

Capsule or oral suspension

Interventions

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ORIC-101

Capsule or oral suspension

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ORIC Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Center

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ORIC-GR-17002

Identifier Type: -

Identifier Source: org_study_id

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