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

NCT02768519 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-06-01

No results posted yet for this study

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

DRUG

OTS167IV

diluted to final concentration with cherry syrup

OTHER

Cherry syrup

Sponsors & Collaborators

  • OncoTherapy Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib · CMAX (A division of IDT Australia Ltd)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768519 on ClinicalTrials.gov