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

NCT03835637 — Phase 1, Completed, 32 participants, ORIC Pharmaceuticals

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03835637
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, basic science
Enrollment	32 (Actual)
Sponsor	ORIC Pharmaceuticals (Industry)
Conditions	Healthy Volunteers
Interventions	ORIC-101 (Drug)
Dates	start 2018-03-23, primary completion 2018-07-04, completion 2018-07-04, first posted 2019-02-08, last updated 2019-02-08
Locations	1 site in United Kingdom

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions
Regimen A	Experimental	Drug: ORIC-101
Regimen B	Experimental	Drug: ORIC-101
Regimen C	Experimental	Drug: ORIC-101
Regimen D	Experimental	Drug: ORIC-101
Regimen F	Experimental	Drug: ORIC-101
Regimen H	Experimental	Drug: ORIC-101
Regimen I	Experimental	Drug: ORIC-101

ORIC-101 (Drug): Capsule or oral suspension

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years, 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

+Locations (1)

Facility	City	Country	Status
Research Center	Nottingham	United Kingdom

My Notes

Public

To Read Reading Read