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
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2018
CompletedFirst Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 8, 2019
CompletedFebruary 8, 2019
February 1, 2019
3 months
February 5, 2019
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
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
Number of Participants With Abnormal Laboratory Values
96 hours post-final dose
Maximum plasma concentration (Cmax)
96 hours post-final dose
- +1 more secondary outcomes
Study Arms (7)
Regimen A
EXPERIMENTALRegimen B
EXPERIMENTALRegimen C
EXPERIMENTALRegimen D
EXPERIMENTALRegimen F
EXPERIMENTALRegimen H
EXPERIMENTALRegimen I
EXPERIMENTALInterventions
Capsule or oral suspension
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Center
Nottingham, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 8, 2019
Study Start
March 23, 2018
Primary Completion
July 4, 2018
Study Completion
July 4, 2018
Last Updated
February 8, 2019
Record last verified: 2019-02