A First Time in Human Study in Healthy Volunteers and Patients

NCT03010787 | Completed Phase 1 DMC

• 1 other identifier: V56501
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs

  Up to 14 days

• Measurement of the concentrations of V565 in ileal fluid following a single dose

  24 hours

Secondary Outcomes (3)

• Evaluation of pharmacokinetic parameter of V565: Cmax

  72 hours

• Evaluation of pharmacokinetic parameter of V565: AUC

  72 hours

• Evaluation of pharmacokinetic parameter of V565: tmax

  72 hours

Study Arms (5)

Part 1

EXPERIMENTAL

Single ascending dose of oral V565

Drug: V565

Part 2 - V565

EXPERIMENTAL

Single dose level of oral V565 TID for 14 days

Drug: V565

Part 1 and 2 - placebo

PLACEBO COMPARATOR

Oral placebo single dose (Part 1) or TID for 14 days (Part 2)

Drug: Placebo

Part 3

EXPERIMENTAL

Single dose of V565 in patient volunteers

Drug: V565

Part 4

EXPERIMENTAL

Single ascending dose of V565 in patients with Crohn's Disease

Drug: V565

Interventions

V565 DRUG

single ascending dose of V565

Part 1

Placebo DRUG

Single and multiple dose

Part 1 and 2 - placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VHsquared Ltd.: lead

Study Sites (1)

Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Suhail Nurbhai, MBChB

  VHsquared Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 5, 2017
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)