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

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ClinicalTrials.gov Identifier: NCT03835637
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Oric Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
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 : March 23, 2018
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : July 4, 2018

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




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 96 hours post-final dose ]
    PK of ORIC-101 as single doses

  2. Area under the curve (AUC) [ Time Frame: 96 hours post-final dose ]
    PK of ORIC-101 as single doses

  3. Number of participants with adverse events [ Time Frame: 96 hours post-final dose ]
    Safety and tolerability of ORIC-101 as single doses

  4. Number of Participants With Abnormal Laboratory Values [ Time Frame: 96 hours post-final dose ]
    Safety and tolerability of ORIC-101 as single doses


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 96 hours post-final dose ]
    Safety and tolerability of ORIC-101 as multiple doses

  4. Number of Participants With Abnormal Laboratory Values [ Time Frame: 96 hours post-final dose ]
    Safety and tolerability of ORIC-101 as multiple doses

  5. Maximum plasma concentration (Cmax) [ Time Frame: 96 hours post-final dose ]
    PK of ORIC-101 as multiple doses

  6. Area under the curve (AUC) [ Time Frame: 96 hours post-final dose ]
    PK of ORIC-101 as multiple doses



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835637


Locations
United Kingdom
Research Center
Nottingham, United Kingdom
Sponsors and Collaborators
Oric Pharmaceuticals

Responsible Party: Oric Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03835637     History of Changes
Other Study ID Numbers: ORIC-GR-17002
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 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