NCT03324555

Study of ORIC-101 in Healthy Adult Subjects

A Phase 1 Single-ascending Dose Study of the Oral Glucocorticoid Receptor Antagonist ORIC-101 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: ORIC Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ORIC-101	Oral suspension

Timeline

• Start date: 2017-10-19
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2017-10-27
• Last updated: 2018-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study