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Study of ORIC-101 in Healthy Adult Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03324555
First Posted: October 27, 2017
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oric Pharmaceuticals
  Purpose
ORIC-GR-17001 is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential. In this study, ORIC-101 will be administered as single-ascending oral doses. The primary objective is to characterize the safety and tolerability of oral ORIC-101.

Condition Intervention Phase
Healthy Volunteers Drug: ORIC-101 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Single-ascending Dose Study of the Oral Glucocorticoid Receptor Antagonist ORIC-101 in Healthy Adult Subjects

Further study details as provided by Oric Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability, as assessed by incidence and severity of adverse events. [ Time Frame: 96 hours post-dose ]

Secondary Outcome Measures:
  • Pharmacokinetics, as assessed by time of observed maximum concentration (Tmax) [ Time Frame: 96 hours post-dose ]
  • Pharmacokinetics, as assessed by maximum concentration observed (Cmax) [ Time Frame: 96 hours post-dose ]
  • Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 to 24 hours post-dose (AUC(0-24)) [ Time Frame: 96 hours post-dose ]
  • Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 to last measurable concentration (AUC(0-last)) [ Time Frame: 96 hours post-dose ]
  • Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 extrapolated to infinity (AUC(0-inf)) [ Time Frame: 96 hours post-dose ]

Estimated Enrollment: 24
Actual Study Start Date: October 19, 2017
Estimated Study Completion Date: April 18, 2018
Estimated Primary Completion Date: December 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORIC-101 Drug: ORIC-101
Oral suspension

Detailed Description:

This is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential.

Subjects will receive a single administration of ORIC-101 oral suspension on a single occasion and will be followed in the clinic for at least 96 hours post-dose. Total subject participation will be approximately 5 weeks from screening until discharge from the study.

The primary objective of the study is to characterize the safety and tolerability of oral ORIC-101 administered as a single dose in adult healthy subjects. The secondary objective of the study is to evaluate the pharmacokinetics of ORIC-101 and its metabolites M1 and M2. The exploratory objective of the study is to assess the pharmacodynamics of ORIC-101 by measurement of serum and urine levels of cortisol and other biological markers in healthy subjects

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males or healthy females of non-child bearing potential
  2. Age 18 to 55 years, inclusive
  3. Weighs more than 50 kilograms (kg), and less than 120 kg, with a body mass index of 18.0 to 32.0 kg/meters squared

Exclusion Criteria:

  1. Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 45 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days
  2. History of any drug or alcohol abuse in the past 2 years
  3. Current smokers and those who have smoked within the last 12 months
  4. Females of childbearing potential (female subjects must have a negative pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 international units per litre (IU/L))
  5. Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
  6. Current disease requiring treatment with systemic corticosteroids.
  7. Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients
  Contacts and Locations
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): NCT03324555


Locations
United States, Florida
Research Center
Miami, Florida, United States, 33126
Sponsors and Collaborators
Oric Pharmaceuticals
  More Information

Responsible Party: Oric Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03324555     History of Changes
Other Study ID Numbers: ORIC-GR-17001
First Submitted: October 25, 2017
First Posted: October 27, 2017
Last Update Posted: December 14, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No