Crohn's DiseasePhase 1NCT03010787
A First Time in Human Study in Healthy Volunteers and Patients
A Phase 1 study testing V565 in people with Crohn's Disease, run by VHsquared Ltd. at 1 site in United Kingdom.
Trial summary
A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- V565
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Mar 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parts 1 and 2
- Adult male subjects aged 18 to 45 years inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
- Body weight between 50.0 and 100.0 kg inclusive.
- Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests
- Part 3
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- Adult male or female subjects aged 18 to 65 years.
- Ileostomy for a minimum of 18 months for a non malignant disease indication.
- A BMI between 18.0 and 32.0 kg/m2 inclusive.
- Body weight between 50.0 and 100.0 kg inclusive.
- Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests
- Part 4
- Adult male or female subjects aged 18 to 65 years.
- A confirmed diagnosis of Crohn's disease for a minimum of 6 months.
- A BMI between 15.0 and 32.0 kg/m2 inclusive.
- Subjects who have no other significant co-morbidity (other than those associated with Crohn's disease).
- Subjects whose medical history, physical examination, clinical laboratory test results and 12-lead ECG have no clinically relevant abnormalities (other than those associated with Crohn's disease).
Who cannot join
- Parts 1 and 2
- A clinically significant abnormal medical history or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.
- A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of the study treatment.
- A history of significant gastrointestinal (GI) disease, including GI motility disorders, GI malignancy or of polyposis coli.
- Previous surgery to the GI tract with the exception of appendectomy.
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- A history of malignancy.
- Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
- Part 3
- A history of Crohn's disease.
- A clinically significant abnormal medical history (other than the condition leading to ileostomy) or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.
- A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- A known hypersensitivity or contraindication to TNF inhibitors or any of the inactive ingredients of the study treatment.
- A known history of heart disease.
- Any clinical evidence of active inflammatory bowel disease.
- Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
- Part 4
- Subjects with severe Crohn's disease such as: those requiring surgery; those with a current abscess; those with a non inflammatory stricture; those with a history of obstruction.
- Having ever received anti-TNF-α therapy or other biologics.
- Required an increase in dose of either steroids or immunosuppressant therapy within the past 6 weeks.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd
London, SE1 1YR
About this study
Official title: A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy
A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565
- Conditions
- Crohn's Disease
- Being tested
- V565, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V565Drug
single ascending dose of V565
V565Drug
Multiple dose
PlaceboDrug
Single and multiple dose
V565Drug
Open-label single dose
V565Drug
Open-label single ascending dose
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Single ascending dose of oral V565 Receives: Drug: V565 |
| Part 2 - V565 | Experimental | Single dose level of oral V565 TID for 14 days Receives: Drug: V565 |
| Part 1 and 2 - placebo | Placebo comparator | Oral placebo single dose (Part 1) or TID for 14 days (Part 2) Receives: Drug: Placebo |
| Part 3 | Experimental | Single dose of V565 in patient volunteers Receives: Drug: V565 |
| Part 4 | Experimental | Single ascending dose of V565 in patients with Crohn's Disease Receives: Drug: V565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs
Measured: Up to 14 days
Measurement of the concentrations of V565 in ileal fluid following a single dose
Measured: 24 hours
Secondary outcomes (3)
Evaluation of pharmacokinetic parameter of V565: Cmax
Measured: 72 hours
Evaluation of pharmacokinetic parameter of V565: AUC
Measured: 72 hours
Evaluation of pharmacokinetic parameter of V565: tmax
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VHsquared Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suhail Nurbhai, MBChB, Study director, VHsquared Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010787
- Sponsor's protocol ID
- V56501
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy
- ClinicalTrials.gov ID
- NCT03010787
- Acronym / sponsor ID
- V56501
- Conditions
- Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VHsquared Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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.
A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: V565Single ascending dose of oral V565 |
| Part 2 - V565 | Experimental | Drug: V565Single dose level of oral V565 TID for 14 days |
| Part 1 and 2 - placebo | Placebo comparator | Drug: PlaceboOral placebo single dose (Part 1) or TID for 14 days (Part 2) |
| Part 3 | Experimental | Drug: V565Single dose of V565 in patient volunteers |
| Part 4 | Experimental | Drug: V565Single ascending dose of V565 in patients with Crohn's Disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Parts 1 and 2
- Part 3
- Part 4
Key exclusion criteria (20 listed)
- Parts 1 and 2
- Part 3
- Part 4
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 |
|---|---|---|
| V565single ascending dose of V565 | Drug | Part 1 |
| V565Multiple dose | Drug | Part 2 - V565 |
| PlaceboSingle and multiple dose | Drug | Part 1 and 2 - placebo |
| V565Open-label single dose | Drug | Part 3 |
| V565Open-label single ascending dose | Drug | Part 4 |
Primary outcome
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs
Time frame: Up to 14 days
Measurement of the concentrations of V565 in ileal fluid following a single dose
Time frame: 24 hours
3 secondary outcomes
Evaluation of pharmacokinetic parameter of V565: Cmax
Time frame: 72 hours
Evaluation of pharmacokinetic parameter of V565: AUC
Time frame: 72 hours
Evaluation of pharmacokinetic parameter of V565: tmax
Time frame: 72 hours
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 5 Jan 2017.
- 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.
Suhail Nurbhai, MBChB study director
VHsquared Ltd.
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 V565 in people with Crohn's Disease, run by VHsquared 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 17 inclusion and 20 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 5 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs (time frame: Up to 14 days). The study lists 2 primary outcomes in all. 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 5 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.