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

NCT01634568 | Completed Phase 1

• 2 other identifiers: V81444-1PD-012011-001975-38
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (5)

• Evaluate the safety of V81444 by assessing the frequency of adverse events

  From screening until 7 days post dosing

• Evaluate the safety of V81444 by assessing laboratory safety assessments

  Lab safety assessments are taken at screening, day minus 1, 24h and 72h and post dosing

• Evaluate the safety of V81444 by assessing ECG

  Taken at screening and until 7 days post dosing

• Evaluate the safety of V81444 by assessing vital signs

  Taken at screening and until 7 days post dosing

• Evaluate the safety of V81444 by assessing physical examination

  Taken at screening and post dosing

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

Single Ascending Doses of V81444 compared to placebo

Drug: V81444

Multiple Ascending Doses

EXPERIMENTAL

Multiple ascending doses of V81444 compared to placebo

Drug: V81444

Interventions

V81444 DRUG

Single ascending oral doses of V81444 and placebo Multiple ascending oral doses of V81444 and placebo

Multiple Ascending Doses; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Steve Warrington

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: July 6, 2012
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

GB (1)