Phase 1 Food Effect Study for Alicaforsen Tablets

Phase 1 study to compare the effect of food on alicaforsen tablet.

Completed

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Key information

Conditions

IBD

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Phase 1 unit

Nottingham, United Kingdom

About this study

A study on healthy male vounteers in a phase 1 unit. Alicaforsen tablets are gievn in a fed and fasted state

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy Volunteer

Exclusion criteria

Drugs of abuse
Alcohol abuse

Treatment and study plan

Alicaforsen

Drug

Alicaforsen tablet

Primary outcomes

Pharmacokinetics

Time frame: 24 hours

Area under the curve recovery of alicaforsen in plasma

Sponsors and collaborators

Lead sponsor

Atlantic Pharmaceuticals Ltd

Industry

Registry information

Official study title

A Two-Period, Randomised, Crossover Study Designed to Evaluate the In Vivo Performance of a Modified Release Formulation of Alicaforsen in Healthy Male Subjects in the Fed and Fasted State

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Mar 22, 2018
Registry last updated: Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed