CClinicalTrials.gg
CompletedNCT03473626Updated Nov 7, 2018

Phase 1 Food Effect Study for Alicaforsen Tablets

A Phase 1 interventional study of Alicaforsen in IBD, sponsored by Atlantic Pharmaceuticals Ltd. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by Atlantic Pharmaceuticals Ltd · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • IBD
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Volunteer

Exclusion criteria

Exclusion Criteria:

  • Drugs of abuse
  • Alcohol abuse
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Alicaforsen tablets

    Regimen A - Alicaforsen tablets with food

    Drug: Alicaforsen

  • Experimental
    alicaforsen tablets

    Regimen B - Alicaforsen tablets without food

    Drug: Alicaforsen

Interventions

  • DrugAlicaforsen

    Alicaforsen tablet

05

What researchers measure

Primary outcomes

  1. Pharmacokinetics

    Area under the curve recovery of alicaforsen in plasma

    Time frame: 24 hours

06

Study locations

1 site
  • Phase 1 unit
    Nottingham, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03473626
Lead sponsor
Atlantic Pharmaceuticals Ltd
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
Mar 16, 2018
Primary completion
Apr 6, 2018
Completion
Apr 6, 2018
Last update
Nov 7, 2018

Study contacts

Chris Dunk
study director · Atlantic Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion