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A First Time in Human Study in Healthy Volunteers and Patients

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ClinicalTrials.gov Identifier: NCT03010787
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
VHsquared Ltd.

Brief Summary:
A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: V565 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Part 1
Single ascending dose of oral V565
Drug: V565
single ascending dose of V565

Experimental: Part 2 - V565
Single dose level of oral V565 TID for 14 days
Drug: V565
Multiple 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
Open-label single dose

Experimental: Part 4
Single ascending dose of V565 in patients with Crohn's Disease
Drug: V565
Open-label single ascending dose




Primary Outcome Measures :
  1. 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 ]
  2. Measurement of the concentrations of V565 in ileal fluid following a single dose [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Evaluation of pharmacokinetic parameter of V565: Cmax [ Time Frame: 72 hours ]
  2. Evaluation of pharmacokinetic parameter of V565: AUC [ Time Frame: 72 hours ]
  3. Evaluation of pharmacokinetic parameter of V565: tmax [ Time Frame: 72 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010787


Locations
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United Kingdom
Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
VHsquared Ltd.
Investigators
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Study Director: Suhail Nurbhai, MBChB VHsquared Ltd.
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Responsible Party: VHsquared Ltd.
ClinicalTrials.gov Identifier: NCT03010787    
Other Study ID Numbers: V56501
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases