Phase 1 Food Effect Study for Alicaforsen Tablets

Phase 1

Completed

• Conditions: IBD
• Interventions: Drug: Alicaforsen

• Registration Number: NCT03473626
• Lead Sponsor: Atlantic Pharmaceuticals Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-03-15
• Study Start: 2018-03-16
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-22
• Primary Completion: 2018-04-06
• Study Completion: 2018-04-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Healthy Volunteer

Exclusion Criteria

• Drugs of abuse
• Alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alicaforsen tablets	Alicaforsen	Regimen A - Alicaforsen tablets with food
alicaforsen tablets	Alicaforsen	Regimen B - Alicaforsen tablets without food

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	24 hours	Area under the curve recovery of alicaforsen in plasma

Trial Locations

Locations (1)

Phase 1 unit; 🇬🇧 Nottingham, United Kingdom