A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men

NCT ID: NCT01634568

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-02-29

Brief Summary

A double-blind, randomised, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male volunteers

Detailed Description

Part A - Single Ascending Dose (SAD) Double-blind, randomised, placebo-controlled, single ascending dose study.

Each study subject will participate in a screen visit, three identical treatment periods, in each of which they will receive a single oral dose of V81444 or placebo in accord-ance with the randomisation schedule, and one post-study visit.

In each treatment period, subjects will be admitted the day before dosing (Day -1) and, subject to satisfactory medical review, discharged in the morning, 4 days later (Day 4).

Part B - Multiple Ascending Dose (MAD) Double-blind, randomised, placebo-controlled, parallel group, multiple ascending dose study

Each study subject will participate in a screen visit, one treatment period in which they will receive repeated oral doses of V81444 or placebo in accordance with the randomisation schedule, and one post-study visit.

In each treatment period, subjects will be admitted the day before dosing (Day -1), dosed daily on Days 1 to 14 and, subject to satisfactory medical review, will be discharged in the morning, 3 days after the final dose (Day 17).

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Single Ascending Dose

Single Ascending Doses of V81444 compared to placebo

Group Type: EXPERIMENTAL

V81444

Intervention Type: DRUG

Single ascending oral doses of V81444 and placebo

Multiple ascending oral doses of V81444 and placebo

Multiple Ascending Doses

Multiple ascending doses of V81444 compared to placebo

Group Type: EXPERIMENTAL

V81444

Intervention Type: DRUG

Single ascending oral doses of V81444 and placebo

Multiple ascending oral doses of V81444 and placebo

Interventions

V81444

Single ascending oral doses of V81444 and placebo

Multiple ascending oral doses of V81444 and placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male volunteers: aged 18 to 45 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication. Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history.

Exclusion Criteria

• have a history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-oesophageal reflux disease or gastritis
• any known malformations that would make OGD difficult or unsafe(Part B only)
• have taken V81444 in any previous investigational study
• have taken any restricted concomitant medication
• have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo or midazolam (Part B only)
• in the 4 calendar months before study drug administration have smoked more than 5 cigarettes per day have consumed more than 28 units of alcohol per week have donated blood or plasma in excess of 500 mL been exposed to any new investigational agent or any other adenosine A2A receptor antagonist used non-steroidal anti-inflammatory drugs regularly had a new tattoo or body piercing
• have any clinically relevant abnormal findings at screening and/or admission
• intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vernalis (R&D) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Warrington

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Medicines Research

Locations

Hammersmith Medicines Research

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2011-001975-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V81444-1PD-01

Identifier Type: -

Identifier Source: org_study_id