A First Time in Human Study in Healthy Volunteers and Patients

January 4, 2017 updated by: VHsquared Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parts 1 and 2

    1. Adult male subjects aged 18 to 45 years inclusive.
    2. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
    3. Body weight between 50.0 and 100.0 kg inclusive.
    4. Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests

  • Part 3

    1. Adult male or female subjects aged 18 to 65 years.
    2. Ileostomy for a minimum of 18 months for a non malignant disease indication.
    3. A BMI between 18.0 and 32.0 kg/m2 inclusive.
    4. Body weight between 50.0 and 100.0 kg inclusive.
    5. Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests

  • Part 4

    1. Adult male or female subjects aged 18 to 65 years.
    2. A confirmed diagnosis of Crohn's disease for a minimum of 6 months.
    3. A BMI between 15.0 and 32.0 kg/m2 inclusive.
    4. Subjects who have no other significant co-morbidity (other than those associated with Crohn's disease).
    5. 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).

Exclusion Criteria:

  • Parts 1 and 2

    1. 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.
    2. A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
    3. A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of the study treatment.
    4. A history of significant gastrointestinal (GI) disease, including GI motility disorders, GI malignancy or of polyposis coli.
    5. Previous surgery to the GI tract with the exception of appendectomy.
    6. A history of malignancy.
    7. Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.

  • Part 3

    1. A history of Crohn's disease.
    2. 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.
    3. A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
    4. A known hypersensitivity or contraindication to TNF inhibitors or any of the inactive ingredients of the study treatment.
    5. A known history of heart disease.
    6. Any clinical evidence of active inflammatory bowel disease.
    7. Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.

  • Part 4

    1. 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.
    2. Having ever received anti-TNF-α therapy or other biologics.
    3. Required an increase in dose of either steroids or immunosuppressant therapy within the past 6 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Part 1
Single ascending dose of oral V565
Drug: V565
single ascending dose of V565
Drug: V565
Multiple dose
Drug: V565
Open-label single dose
Drug: V565
Open-label single ascending dose
EXPERIMENTAL: Part 2 - V565
Single dose level of oral V565 TID for 14 days
Drug: V565
single ascending dose of V565
Drug: V565
Multiple dose
Drug: V565
Open-label single dose
Drug: V565
Open-label single ascending dose
PLACEBO_COMPARATOR: Part 1 and 2 - placebo
Oral placebo single dose (Part 1) or TID for 14 days (Part 2)
Drug: Placebo
Single and multiple dose
EXPERIMENTAL: Part 3
Single dose of V565 in patient volunteers
Drug: V565
single ascending dose of V565
Drug: V565
Multiple dose
Drug: V565
Open-label single dose
Drug: V565
Open-label single ascending dose
EXPERIMENTAL: Part 4
Single ascending dose of V565 in patients with Crohn's Disease
Drug: V565
single ascending dose of V565
Drug: V565
Multiple dose
Drug: V565
Open-label single dose
Drug: V565
Open-label single ascending dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Up to 14 days
Measurement of the concentrations of V565 in ileal fluid following a single dose
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Evaluation of pharmacokinetic parameter of V565: Cmax
Time Frame: 72 hours
72 hours
Evaluation of pharmacokinetic parameter of V565: AUC
Time Frame: 72 hours
72 hours
Evaluation of pharmacokinetic parameter of V565: tmax
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VHsquared Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V56501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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