Evaluation of Immediate Release Tablet

Invasive Aspergillosis Clinical Trial

Official title: F901318 - A Two Part Study Designed to Evaluate the Single and Multiple Dose Pharmacokinetics of an Immediate Release Tablet Formulation of F901318

Status Completed

Clinical Trial Summary

Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast.

Evaluation of multiple dose pharmacokinetics and tolerability

Clinical Trial Description

The study will be split into 2 parts, Part 1, ( A and B), and Part 2.

Part 1A Part 1A of the study will be a single centre, open label, 2-way crossover in healthy male and female volunteers and will assess the relative bioavailability of a single 360 mg dose (as 3 x 120mg tablets) of F901318 IR tablet formulation in comparison to a 360 mg dose of an SDD suspension for oral dosing. It is planned that 10 volunteers will be enrolled to Part 1A of the study. These 10 subjects will continue into Part 1B of the study.

There will be a minimum washout of 10 days between doses provided to volunteers.

Following Part 1A there will be a two week period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 1B, a decision will be made using the available data, on whether the dose of F901318 IR tablet formulation should be altered. Dose will be altered by amending the number of units dosed.

Part 1B Following the dose decision meeting where data obtained in Part 1A of the study is reviewed, the selected dose of F901318 IR tablet formulation will be assessed in a further single centre, open label, 2-way crossover in healthy male and female volunteers. The selected dose will be administered in the fed (30 minutes following an FDA high fat meal) and fasted states in a randomised fashion. .

There will be a minimum washout of 10 days between doses provided to volunteers.

Following Part 1B there will period a period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 2, a decision will be made using the available data, on the dose of F901318 IR formulation to be dosed in Part 2. Dose will be altered by amending the number of units dosed. It will also be determined if doses in Part 2 will be administered in the fed or fasted state.

Part 2 In part 2, the dose(s) anticipated to yield therapeutic plasma concentrations will be tested over a 10-day period. This will be a double blind placebo controlled, randomised, parallel group design in 10 healthy male and female subjects, 8 taking active compound and 2 taking placebo. In order to mimic the expected treatment schedule in phase 2 trials, it is anticipated that there will be a loading dose given over 1 or 2 days, followed by once daily or twice daily doses of study drug up to a total of 10 days.

In both parts of the study, blood will be drawn for safety and pharmacokinetic evaluation. Adverse events, vital signs and 12 lead ECGs will be monitored throughout. In Part 1, Holter monitoring will be performed for 12 hours after each dose. Part 2, ECG Holter monitoring will be performed on Days 1 and 10 only. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

• NCT number: NCT02808741
• Study type: Interventional
• Source: F2G Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Completion date: November 2016