Single and Multiple Ascending Dose Study of V158866 in Healthy Volunteers

Vernalis Therapeutics

Status and phase

Completed

Phase 1

Conditions

First in Man Study

Treatments

Drug: V158866

Study type

Interventional

Funder types

Industry

Identifiers

NCT01634529

V158866-1Pa-01

Details and patient eligibility

About

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

Full 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

Enrollment

50 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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