Single and Multiple Ascending Dose Study of V158866 in Healthy Volunteers

NCT01634529 | Completed Phase 1

• 1 other identifier: V158866-1Pa-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether V158866 is safe when given to healthy male subjects in single and multiple doses.

Conditions

First in Man Study

Outcome Measures

Primary Outcomes (4)

• Evaluate the safety of V158866 by assessing adverse events

  Throughout the dosing phase with specific enquiries pre-dose and at 1, 2, 8, 24, 48 and 72 hours post-dose and at the post-study visit.

• Evaluate the safety of V158866 by assessing vital signs

  screen, Day -1, before and after each dose of V158866 or placebo (within 1 hour pre-dose and at 30 minutes (supine/semi-recumbent only), 1, 2, 3, 4, 8, 12, 24, 36, 48, 72 hours post-dose), post-study visit.

• Evaluate the safety of V158866 by assessing ECGs

  At screen, before and after each dose of V158866 or placebo (within 1 hour pre-dose and at 1, 2, 4, 8, 12, 24 and 72 hours post-dose), post-study visit.

• Evaluate the safety of V158866 by assessing safety labs

  At screen, Day 1, 24 hours and 72 hours after each dose of V158866 or placebo, and at the post-study visit.

Secondary Outcomes (2)

• Blood concentration profile of V158866

  Samples will be collected within 15 minutes pre-dose and at 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48 and 72 hours after each dose

• Measurement of FAAH activity and endocannabinoids

  Up to 7 days post dosing

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

Single ascending doses of V158866 compared to Placebo

Drug: V158866

Multiple ascending doses

EXPERIMENTAL

Multiple ascending doses of V158866 compared to Placebo

Drug: V158866

Interventions

V158866 DRUG

Single ascending oral doses of V158866 and Placebo

Single Ascending Dose

Eligibility Criteria

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

You may qualify if:

• Subjects must:
• be healthy male subjects aged 18 to 45 years inclusive
• Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive
• be able to provide a semen sample
• be willing to use an effective method of contraception (see Section 6.1) for the duration of the study and for 4 months after the last dose of study medication
• be able to comply with the requirements of the entire study
• give written informed consent

You may not qualify if:

• Subjects must not:
• intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication
• have had a vasectomy
• have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
• have multiple drug allergies or be allergic to any of the components of V158866 study medication or its matching placebo (see Section 7)
• have smoked more than 5 cigarettes per day in the 6 calendar months before study drug administration
• consume more than 28 units of alcohol per week, or have a significant history of alcohol abuse
• have a positive test for alcohol or drugs of abuse at screening or admission to any of the dosing sessions
• have donated blood or plasma in excess of 500 mL within 4 months before study drug administration
• have been exposed to any new investigational agent within 3 months before study drug administration
• have clinically relevant abnormal findings on vital signs
• have clinically significant abnormalities on laboratory screening tests
• have clinically relevant abnormal physical findings on examination
• have clinically relevant abnormal findings on 12-lead ECG
• have a mean QTc corrected using Bazett's correction (QTcB) at screening \>430 msec (from 3 supine ECGs, performed at least 5 minutes apart)

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead

Study Sites (1)

Hammersmith Medicines Research Limited

London, NW10 7EW, United Kingdom

Location

Study Officials

• Steve Warrington, MD

  Hammersmith Medicines Research Limited

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 6, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

GB (1)