NCT02768519

Study to Evaluate Systemic Bioavailability of Oral OTS167 in Healthy Adult Subjects

A Phase 1, Randomised, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Systemic Bioavailability of Oral OTS167 Under Fed and Fasting Conditions in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: OncoTherapy Science, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the indicative bioavailability of a single oral dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing. Eleven male and female healthy participants aged 45 years and over will be entered into this phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of OTS167 when administered by the oral route. Correlative studies include evaluation of safety endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the safety and tolerability of oral dosing from lower dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	OTS167IV	diluted to final concentration with cherry syrup
OTHER	Cherry syrup

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-05-11
• Last updated: 2017-06-01

Locations

1 site across 1 country: Australia