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

• Sponsor: ORIC Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03835637
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 7
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ORIC-101	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects
• Actual Study Start Date: Mar 23, 2018
• Actual Primary Completion Date: Jul 4, 2018
• Actual Study Completion Date: Jul 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum plasma concentration (Cmax) [96 hours post-final dose]

   PK of ORIC-101 as single doses

2. Area under the curve (AUC) [96 hours post-final dose]

   PK of ORIC-101 as single doses

3. Number of participants with adverse events [96 hours post-final dose]

   Safety and tolerability of ORIC-101 as single doses

4. Number of Participants With Abnormal Laboratory Values [96 hours post-final dose]

   Safety and tolerability of ORIC-101 as single doses

Secondary Outcome Measures

1. Maximum plasma concentration (Cmax) [96 hours post-final dose]

   Comparison of the PK of ORIC-101 in the presence or absence of food

2. Area under the curve (AUC) [96 hours post-final dose]

   Comparison of the PK of ORIC-101 in the presence or absence of food

3. Number of participants with adverse events [96 hours post-final dose]

   Safety and tolerability of ORIC-101 as multiple doses

4. Number of Participants With Abnormal Laboratory Values [96 hours post-final dose]

   Safety and tolerability of ORIC-101 as multiple doses

5. Maximum plasma concentration (Cmax) [96 hours post-final dose]

   PK of ORIC-101 as multiple doses

6. Area under the curve (AUC) [96 hours post-final dose]

   PK of ORIC-101 as multiple doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Nottingham		United Kingdom

Sponsors and Collaborators

• ORIC Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ORIC Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03835637
• Other Study ID Numbers: ORIC-GR-17002
• First Posted: Feb 8, 2019
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• 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

Study Results

No Results Posted as of Feb 8, 2019