Phase 1 Food Effect Study for Alicaforsen Tablets

Atlantic Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: IBD

Treatments: Drug: Alicaforsen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03473626

ACH HV-AO-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 15 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Volunteer

Exclusion criteria

• Drugs of abuse
• Alcohol abuse

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Alicaforsen tablets

Experimental group

Description:

Regimen A - Alicaforsen tablets with food

Treatment:

Drug: Alicaforsen

alicaforsen tablets

Experimental group

Description:

Regimen B - Alicaforsen tablets without food

Treatment:

Drug: Alicaforsen