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

A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ORIC-101

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Regimen A	Drug: ORIC-101; Capsule or oral suspension
EXPERIMENTAL: Regimen B	Drug: ORIC-101; Capsule or oral suspension
EXPERIMENTAL: Regimen C	Drug: ORIC-101; Capsule or oral suspension
EXPERIMENTAL: Regimen D	Drug: ORIC-101; Capsule or oral suspension
EXPERIMENTAL: Regimen F	Drug: ORIC-101; Capsule or oral suspension
EXPERIMENTAL: Regimen H	Drug: ORIC-101; Capsule or oral suspension
EXPERIMENTAL: Regimen I	Drug: ORIC-101; Capsule or oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	PK of ORIC-101 as single doses	96 hours post-final dose
Area under the curve (AUC)	PK of ORIC-101 as single doses	96 hours post-final dose
Number of participants with adverse events	Safety and tolerability of ORIC-101 as single doses	96 hours post-final dose
Number of Participants With Abnormal Laboratory Values	Safety and tolerability of ORIC-101 as single doses	96 hours post-final dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	Comparison of the PK of ORIC-101 in the presence or absence of food	96 hours post-final dose
Area under the curve (AUC)	Comparison of the PK of ORIC-101 in the presence or absence of food	96 hours post-final dose
Number of participants with adverse events	Safety and tolerability of ORIC-101 as multiple doses	96 hours post-final dose
Number of Participants With Abnormal Laboratory Values	Safety and tolerability of ORIC-101 as multiple doses	96 hours post-final dose
Maximum plasma concentration (Cmax)	PK of ORIC-101 as multiple doses	96 hours post-final dose
Area under the curve (AUC)	PK of ORIC-101 as multiple doses	96 hours post-final dose

Collaborators and Investigators

• Sponsor: ORIC Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2018
• Primary Completion (ACTUAL): July 4, 2018
• Study Completion (ACTUAL): July 4, 2018

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (ACTUAL): February 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ORIC-GR-17002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No