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.

Phase 1

Completed

• Conditions: Cancer; Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lung - Small cell

• Registration Number: ACTRN12616000043437
• Lead Sponsor: CMAX - a division of IDT Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Healthy males or females aged 45 years or over
- Females must be of non-child bearing potential

Exclusion Criteria

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases.
- Orthostatic blood pressure changes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the indicative bioavailability of a single dose of OTS167 from analysis of blood samples collected following dose administration.[Blood samples will be collected on Day 1 at pre-dose then at 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 7 hours and 24 hours post each dose of study drug.<br>];To evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing from the assessment of Cmax, Tmax, AUC, t1/2 for OTS167.[Blood samples will be collected on Day 1 at pre-dose then at 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 7 hours and 24 hours post each dose of study drug.<br>]

Secondary Outcome Measures

Name	Time	Method
Safety of OTS167 from adverse event documentation[Assessment of adverse events prior to the first dose of study drug and at Day 1, Day 2, Day 4, and 7 days following the last dose of study drug. ]