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OpenTrials
Completed

NCT Number: NCT03835637

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Center

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORIC-101

Drug

Capsule or oral suspension

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ORIC Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2019
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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