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Study of ORIC-101 in Healthy Adult Subjects

2017-11-05 23:53:11 | BioPortfolio

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.

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

Study Design

Conditions

Healthy Volunteers

Intervention

ORIC-101

Location

Research Center
Miami
Florida
United States
33126

Status

Recruiting

Source

Oric Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-11-05T23:53:11-0500

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