First in Man StudyPhase 1NCT01634529
Single and Multiple Ascending Dose Study of V158866 in Healthy Volunteers
A Phase 1 study testing V158866 in people with First in Man Study, run by Vernalis (R&D) Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether V158866 is safe when given to healthy male subjects in single and multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- First in Man Study
- What is being tested?
- V158866
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research Limited
London, NW10 7EW
About this study
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
The purpose of this study is to investigate whether V158866 is safe when given to healthy male subjects in single and multiple doses.
Read the 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
- Conditions
- First in Man Study
- Being tested
- V158866
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V158866Drug
Single ascending oral doses of V158866 and Placebo
V158866Drug
Multiple ascending oral doses of V158866 and Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Single ascending doses of V158866 compared to Placebo Receives: Drug: V158866 |
| Multiple ascending doses | Experimental | Multiple ascending doses of V158866 compared to Placebo Receives: Drug: V158866 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of V158866 by assessing adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 7 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First in Man StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vernalis (R&D) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Warrington, MD, Principal investigator, Hammersmith Medicines Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634529
- Sponsor's protocol ID
- V158866-1Pa-01
- Status last verified
- Jul 2012
- First submitted
- 21 Jul 2011
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01634529
- Acronym / sponsor ID
- V158866-1Pa-01
- Conditions
- First in Man Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vernalis (R&D) LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether V158866 is safe when given to healthy male subjects in single and multiple doses.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: V158866Single ascending doses of V158866 compared to Placebo |
| Multiple ascending doses | Experimental | Drug: V158866Multiple ascending doses of V158866 compared to Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V158866Single ascending oral doses of V158866 and Placebo | Drug | Single Ascending Dose |
| V158866Multiple ascending oral doses of V158866 and Placebo | Drug | Multiple ascending doses |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
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
Measurement of FAAH activity and endocannabinoids
Time frame: Up to 7 days post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Warrington, MD principal investigator
Hammersmith Medicines Research Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V158866 in people with First in Man Study, run by Vernalis (R&D) Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.