NCT03473626

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

21 days

First QC Date

March 15, 2018

Last Update Submit

November 6, 2018

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    Area under the curve recovery of alicaforsen in plasma

    24 hours

Study Arms (2)

Alicaforsen tablets

EXPERIMENTAL

Regimen A - Alicaforsen tablets with food

Drug: Alicaforsen

alicaforsen tablets

EXPERIMENTAL

Regimen B - Alicaforsen tablets without food

Drug: Alicaforsen

Interventions

AlicaforsenDRUG

Alicaforsen tablet

Alicaforsen tabletsalicaforsen tablets

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteer

You may not qualify if:

  • Drugs of abuse
  • Alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase 1 unit

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

alicaforsen

Study Officials

  • Chris Dunk

    Atlantic Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

March 16, 2018

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

November 7, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)