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.

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The primary purpose of this study is to evaluate the absorption of the oral form of drug OTS167 in healthy volunteers, and to establish its safety. Who is it for? You may be eligible to participate in this study if you are a healthy male or female volunteer aged 45 years or over. Study details: All participants will be randomly allocated (by chance) to receive either the active drug, given in cherry syrup, or cherry syrup alone. This study will recruit participants in three stages. Those recruited to the first two stages will receive one dose on the morning of day 1 of either the active or inactive cherry syrup mixture after fasting for 10 hours (liquid will be permitted). Those recruited to the third stage will receive two separate doses of either the active or inactive cherry syrup mixture at least 4 days apart; once after fasting for 10 hours, and once in a fed state following a high fat, high calorie breakfast. All participants across all stages will have a number of blood samples taken over the 24 hours following each dose, and will be monitored for 4 days for side effects of the drug. It is hoped that the findings of this trial will provide further information on the absorption and distribution within the body of this oral formulation of OTS167, which may provide a more tolerable and convenient method of dosing for cancer patients.

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