Single and Multiple Ascending Dose Study of V158866 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:
NCT01634529
First received: July 21, 2011
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
First in Man Study
Drug: V158866
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of V158866 in Healthy Volunteers

Further study details as provided by Vernalis (R&D) Ltd:

Primary Outcome Measures:
  • Evaluate the safety of V158866 by assessing adverse events [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Evaluate the safety of V158866 by assessing vital signs [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Evaluate the safety of V158866 by assessing ECGs [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Evaluate the safety of V158866 by assessing safety labs [ Time Frame: At screen, Day 1, 24 hours and 72 hours after each dose of V158866 or placebo, and at the post-study visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood concentration profile of V158866 [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Measurement of FAAH activity and endocannabinoids [ Time Frame: Up to 7 days post dosing ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Ascending Dose
Single ascending doses of V158866 compared to Placebo
Drug: V158866
Single ascending oral doses of V158866 and Placebo
Experimental: Multiple ascending doses
Multiple ascending doses of V158866 compared to Placebo
Drug: V158866
Multiple ascending oral doses of V158866 and Placebo

Detailed Description:

A first in human study:

To evaluate the safety and tolerability of single and multiple doses of V158866 in healthy male subjects To assess the pharmacokinetics (PK) of V158866 in healthy male subjects To assess the pharmacodynamics (PD) of V158866 by determining whether V158866 inhibits fatty acid amide hydrolase (FAAH ) in healthy male subjects

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
  • be seropositive for hepatitis B, hepatitis C or HIV viruses at screening
  • have any medical or social reasons for not participating in the study raised by their General Practitioner/primary care physician
  • have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
  • have had treatment with any prescription medicine within one month or any over-the-counter medicines, except for paracetamol, within one week before study drug administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634529

Locations
United Kingdom
Hammersmith Medicines Research Limited
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Vernalis (R&D) Ltd
Investigators
Principal Investigator: Steve Warrington, MD Hammersmith Medicines Research Limited
  More Information

No publications provided

Responsible Party: Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier: NCT01634529     History of Changes
Other Study ID Numbers: V158866-1Pa-01
Study First Received: July 21, 2011
Last Updated: July 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on July 23, 2014