IBDPhase 1NCT03473626
Phase 1 Food Effect Study for Alicaforsen Tablets
A Phase 1 study testing Alicaforsen in people with IBD, run by Atlantic Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial summary
Phase 1 study to compare the effect of food on alicaforsen tablet. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- IBD
- What is being tested?
- Alicaforsen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2018to 6 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteer
Who cannot join
- Drugs of abuse
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- IBD
- Being tested
- Alicaforsen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlicaforsenDrug
Alicaforsen tablet
| Study group | Role | What they receive |
|---|---|---|
| Alicaforsen tablets | Experimental | Regimen A - Alicaforsen tablets with food Receives: Drug: Alicaforsen |
| alicaforsen tablets | Experimental | Regimen B - Alicaforsen tablets without food Receives: Drug: Alicaforsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Area under the curve recovery of alicaforsen in plasma
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start16 Mar 2018
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Dunk, Study director, Atlantic Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473626
- Sponsor's protocol ID
- ACH HV-AO-101
- Status last verified
- Nov 2018
- First submitted
- 15 Mar 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03473626
- Acronym / sponsor ID
- ACH HV-AO-101
- Conditions
- IBD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Atlantic Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alicaforsen tablets | Experimental | Drug: AlicaforsenRegimen A - Alicaforsen tablets with food |
| alicaforsen tablets | Experimental | Drug: AlicaforsenRegimen B - Alicaforsen tablets without food |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Volunteer
Key exclusion criteria (2 listed)
- Drugs of abuse
- Alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlicaforsenAlicaforsen tablet | Drug | Alicaforsen tablets, alicaforsen tablets |
Primary outcome
Pharmacokinetics
Time frame: 24 hours
Area under the curve recovery of alicaforsen in plasma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Dunk study director
Atlantic Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alicaforsen in people with IBD, run by Atlantic Pharmaceuticals Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.