Last updated on August 2017

A FIH Study to Investigate the Safety Tolerability and PK of P218


Brief description of study

The First in Human (FIH) study is separated into two parts: - The first part is a Single Ascending Dose (SAD), double-blinded, randomized and placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug). - The second part is a food effect cohort with an open-labelled, randomized fed/fasted cross-over design. The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics (PK) of P218 in healthy volunteers.

Detailed Study Description

The study is divided into two parts: Part A This is a double-blind randomised, placebo-controlled, parallel group, ascending dose study and will comprise up to eight fasted cohorts (8 volunteers in each) that will receive a single ascending dose (SAD) of P218 to assess its safety, tolerability and pharmacokinetic profile. Each subject will participate in only one dose group and will receive only one dose of study drug. In each cohort, 2 and 6 subjects will be randomized to placebo and P218, respectively. The data obtained from each cohort will undergo a formal review by the Safety Review Team (SRT). SRT will confirm that it is safe to proceed with the next dose/cohort. Part B This is the pilot food effect evaluation. Once predicted human efficacious concentrations of P218 and a safe exposure window (at least 3-fold above the targeted therapeutic exposure in order to account for a possible increase in exposure with food) has been achieved in Part A, a new cohort of 8 subjects (all receiving active drug) will be evaluated for food effect in an open-label, randomized fed/fasted crossover design. Subjects participating in this food effect cohort will be randomized to two single dose sessions (fed/fasted). The second dose will be administered after a washout period of at least 5x observed human half-life (T1/2), to be confirmed once PK data are available from the relevant doses from Part A. Primary objectives: - To investigate the safety and tolerability of single escalating oral doses of P218 when administered to healthy volunteers (men and Women of Non Child Bearing Potential (WNCBP)) under fasted conditions. Secondary objectives: - To describe the pharmacokinetics of P218 and its major glucuronide metabolite (P218 acyl glucuronide) in healthy volunteers (men and WNCBP) after administration of single escalating oral doses - To investigate the effect of a high fat meal on the pharmacokinetics and safety/tolerability of P218. This study incorporates the use of an adaptive design. All anticipated dosing levels can be adjusted in accordance with PK, safety and tolerability data collected up to the decision making time-point.

Clinical Study Identifier: NCT02885506

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Ulrike Lorch, MD

Richmond Pharmacology Ltd
Croydon, United Kingdom
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