Study of ORIC-101 in Healthy Adult Subjects

NCT03324555 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ORIC-GR-17001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability, as assessed by incidence and severity of adverse events.

  96 hours post-dose

Secondary Outcomes (5)

• Pharmacokinetics, as assessed by time of observed maximum concentration (Tmax)

  96 hours post-dose

• Pharmacokinetics, as assessed by maximum concentration observed (Cmax)

  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))

  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))

  96 hours post-dose

• Pharmacokinetics, as assessed by area under the concentration versus time curve from time 0 extrapolated to infinity (AUC(0-inf))

  96 hours post-dose

Study Arms (1)

ORIC-101

EXPERIMENTAL

Drug: ORIC-101

Interventions

ORIC-101 DRUG

Oral suspension

ORIC-101

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or healthy females of non-child bearing potential
• Age 18 to 55 years, inclusive
• 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

You may not qualify if:

• 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
• 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 (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))
• 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

Sponsors & Collaborators

• ORIC Pharmaceuticals: lead

Study Sites (1)

Research Center

Miami, Florida, 33126, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 27, 2017
• Study Start: October 19, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)