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NCT03473626 Clinical Trial

Phase 1 Food Effect Study for Alicaforsen Tablets

IBD Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03473626
Other study ID # ACH HV-AO-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 16, 2018
Est. completion date April 6, 2018

Study information
Verified date November 2018
Source Atlantic Pharmaceuticals Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date April 6, 2018
Est. primary completion date April 6, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy Volunteer

Exclusion Criteria:

- Drugs of abuse

- Alcohol abuse

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alicaforsen
Alicaforsen tablet

Locations
Country Name City State
United Kingdom Phase 1 unit Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Atlantic Pharmaceuticals Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics Area under the curve recovery of alicaforsen in plasma 24 hours
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