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A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764892
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Vernalis (R&D) Ltd

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date May 6, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy. [ Time Frame: Up to 27 hours after a single dose ]
Plasma concentrations of V81444 and binding of [11C]SCH442416 radioligand to brain A2A receptors using PET before and after V81444 dosing to determine occupancy of A2A receptors by V81444.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Cognitive function using functional MRI [ Time Frame: 5 hours after dosing ]
  • Change versus placebo in proportion of subjects with adverse events [ Time Frame: Up to 7 Days after last dose ]
  • Change versus placebo in proportion of subjects with abnormal laboratory findings [ Time Frame: Up to 7 Days after last dose ]
  • Change versus placebo in proportion of subjects with clinically significant abnormalities on vital signs [ Time Frame: Up to 7 Days after last dose ]
  • Change versus placebo in proportion of subjects with clinically significant abnormalities in 12-lead ECG [ Time Frame: Up to 7 Days after last dose ]
  • Change versus placebo in proportion of subjects with clinically significant abnormalities on physical examination [ Time Frame: Up to 7 Days after last dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease
Official Title  ICMJE An Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male Volunteers
Brief Summary The main purpose of the study is to identify the best dose of V81444 to use in future trials in patients with Parkinson's disease. The study will also explore the effects of V81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). It will also check how safe V81444 is and how well it is tolerated after dosing.
Detailed Description

In this Phase I, single-centre, open-label, adaptive, single-dose study at multiple dose levels, the relationship between dose and plasma concentration of orally administered V81444 to brain A2A RO was investigated in 6 healthy male volunteers. In addition, the effects of V81444 on regional brain activity and perfusion during tests of cognitive function, and the safety and tolerability of V81444 were assessed. For each subject, the study consisted of a screening visit, a baseline visit, a treatment period, and a safety follow-up visit. The dose of V81444 and timing of scans performed were defined in the protocol for the first 2 subjects only. The dose, nature and timings of assessments for subsequent subjects were determined based on review of emerging receptor binding, pharmacokinetic (PK), pharmacodynamic (PD) and safety information.

In each treatment period, subjects were admitted to the unit on the day before dosing (Day -1), received a single oral dose of V81444 on Day 1 and, subject to satisfactory medical review, were discharged a minimum of 12 h after dosing. Overall, 3 doses of V81444 were assessed (250 mg, 50 mg, and 100 mg), with 2 subjects included at each dose level. PD assessments were performed at baseline and after each dose of V81444 using PET (with the A2A radioligand, to measure brain A2A RO, as well as MRI techniques to investigate the effects of V81444 on regional brain activity and perfusion during cognitive function tests. PK parameters were assessed by assay of V81444 concentration in plasma. Safety and tolerability were assessed by monitoring physical examination findings, adverse events (AEs), vital signs, 12 lead electrocardiogram (ECG) and clinical laboratory safety tests.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: V81444
Single oral dose of V81444
Study Arms  ICMJE Experimental: V81444
Single oral dose of V81444
Intervention: Drug: V81444
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2016)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male volunteers: aged 25 to 55 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:

  • Any significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study.

Specific exclusion criteria relate to

  • usual caffeine intake and willingness to abstain from caffeine
  • history or evidence of clinically significant gastro-intestinal disease
  • presence of structural brain abnormality
  • contraindications or cautions for MRI scanning
  • clotting test results
  • exposure to significant levels of ionising radiation in the past
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764892
Other Study ID Numbers  ICMJE V81444-1PD-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vernalis (R&D) Ltd
Study Sponsor  ICMJE Vernalis (R&D) Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vernalis (R&D) Ltd
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP