Phase 1 Food Effect Study for Alicaforsen Tablets

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03473626

Enrollment

Registered

2018-03-22

Start date

2018-03-16

Completion date

2018-04-06

Last updated

2018-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

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

Interventions

DRUGAlicaforsen

Alicaforsen tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Volunteer

Exclusion criteria

* Drugs of abuse * Alcohol abuse

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	24 hours	Area under the curve recovery of alicaforsen in plasma

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026