A Phase 1 Study of ORIC-101 in Healthy Adults (QCL118164)
Research type
Research Study
Full title
A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects
IRAS ID
238146
Contact name
Leonard Reyno
Contact email
Sponsor organisation
Oric Pharmaceuticals
Eudract number
2017-004638-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 29 days
Research summary
The Sponsor is developing the study drug, ORIC-101, to strengthen the response of certain cancers to chemotherapy by restricting glucocorticoid (GC) activity in the body. GCs are a type of hormone present in almost every single cell in the body. They mainly affect metabolism, cell growth, cell death, inflammation, mood and brain function.
It has been shown that GCs may also cause the immune system not to work properly. Several studies have demonstrated that too much GC activity in the body is a possible reason for certain cancers not responding properly to chemotherapy.
The purpose of this study is to see how changing the formulation (recipe) of the study drug affects how well the study drug is taken up by the body when given by mouth. If a suitable formulation is identified, the study will look at the safety and tolerability of giving the study drug for 10 days. The study will also look at the safety and tolerability of ORIC-101.
The study will consist of up to 2 parts (optional Part 2) involving up to 48 healthy male and female subjects. In Part 1, up to 5 groups of 6 subjects (2 optional groups) will receive one dose of the study drug in up to 2 dosing periods (optional Period 2).
In Part 2 (optional), up to 3 groups of 6 subjects (1 optional group) will receive a once or twice a day dose of a chosen formulation of ORIC-101 for 10 days. The dose and formulation will be chosen based on data from Part A.
REC name
HSC REC A
REC reference
18/NI/0039
Date of REC Opinion
7 Mar 2018
REC opinion
Favourable Opinion