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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634568
• Other study ID #: V81444-1PD-01
• Secondary ID: 2011-001975-38
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2012
• Last updated: July 9, 2012
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Vernalis (R&D) Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• V81444
Single ascending oral doses of V81444 and placebo Multiple ascending oral doses of V81444 and placebo

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Vernalis (R&D) Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety of V81444 by assessing the frequency of adverse events		From screening until 7 days post dosing	No
Primary	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	No
Primary	Evaluate the safety of V81444 by assessing ECG		Taken at screening and until 7 days post dosing	No
Primary	Evaluate the safety of V81444 by assessing vital signs		Taken at screening and until 7 days post dosing	No
Primary	Evaluate the safety of V81444 by assessing physical examination		Taken at screening and post dosing	No