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Phase 1 Food Effect Study for Alicaforsen Tablets

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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