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Substance DependencePhase 1NCT00513279

To Investigate If Single Doses Of GSK618334 Are Safe And To Investigate Blood Levels Of GSK618334

A Phase 1 study testing GSK618334 in people with Substance Dependence, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

GSK618334 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Substance Dependence
What is being tested?
GSK618334
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
28 Jun 2007to 4 Oct 2007
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 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male subject, aged between 18 and 50 years of age inclusive.
  • Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
  • Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical, psychiatric or laboratory evaluation, including 12-lead ECG and 24 hour Holter ECG. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range for this age group may be included only if the Investigator considers the finding will not introduce additional risk factors and will not interfere with the study procedures.
  • Signed and dated written informed consent prior to participation in the study.
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Who cannot join

  • The subject has a positive pre-study urine drug screen including alcohol at the screening visit and/or prior to receiving the first dose of study medication. Drugs that will be screened for are amphetamines, barbiturates, cocaine, opiates, cannabinoids, methadone, benzodiazepines, phencyclidine (PCP) and cotinine. If any of these tests are positive the investigator may re-test the subject and the subject may be included if the re-test is negative.
  • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
  • Abuse of alcohol defined as an average weekly intake of greater than 28 units or an average daily intake of greater than 4 units.
  • The subject has clinically significant elevations in liver function tests (LFT) that are elevated above the reference range at pre-study screening and remain elevated with a repeat LFT, and/or prior to receiving the first dose of study medication.
  • Consumption of grapefruit juice or grapefruit within 7 days prior to receiving the first dose of study medication.
  • Any subject who is not prepared to eat the standard meals provided by the Clinical Pharmacology Research Unit (CPRU) during the study.
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  • Participation in a clinical trial with a new chemical entity within 4 months before the first dose of study medication or marketed compound within 3 months before receiving the first dose of study medication.
  • Use of prescription or non-prescription drugs, including, over the counter remedies, vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to receiving the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Loss of more than 600mL blood during the 120 days before study start.
  • History or presence of allergy to the study drug or drugs of this class, or a history of other allergy that, in the opinion of the physician responsible, contraindicates his participation in the study.
  • History of regular use of tobacco- or nicotine-containing products within 6 months of the start of the study (i.e., from Screening Visit 1).
  • An unwillingness of the male subject to use condoms or practise abstinence to prevent exposure of a female partner to semen from the start of the study (i.e., from Screening Visit 1) until 90 days after the study treatment has ended.
  • History of psychiatric disorder either Axis I or II by DSM-IV.
  • History or presence of respiratory illnesses, gastrointestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • The subject has a screening ECG with values outside of ranges defined in the protocol.
  • The subject has a screening heart rate <50 or >100 bpm and a systolic blood pressure >140 and <100 mmHg and a diastolic blood pressure >90 and <60 mmHg in the semi-supine position.
  • The subject has a reduction in systolic blood pressure of 20 mmHg or more, or a reduction in diastolic blood pressure of 10 mmHg or more on standing compared to the supine measurement at screening.
  • History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
  • The subject is unable to abstain from strenuous physical activity for 24 h prior to the screening visit and for 24 h prior to admission for each treatment period.
  • Inability of the subject to be successfully trained in tests of cognition prior to receiving the first dose of study medication.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    Harrow, Middlesex, HA13UJ

Other trials in United Kingdom

About this study

Official title: A First Time in Human, Blinded, Randomised, Placebo-Controlled, Two-cohort Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single Oral Escalating Doses of GSK618334 in Healthy Male Volunteers

GSK618334 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers.

Being tested
GSK618334, GSK618334 matching placebo tablets
Keywords
Safety,, GSK618334, pharmacokinetics,, repeat dose,, tolerability,, pharmacodynamics,, placebo,
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK618334Drug

    GSK618334 will be available as white to off-white coated tablets. GSK618334 will be swallowed with 250 milliliters (mL) of water.

  • GSK618334 matching placebo tabletsDrug

    GSK618334 placebo tablets visually match the active GSK618334 tablets and contain the same excipients except for the omission of the active ingredient. GSK618334 matching placebo will be swallowed with 250 mL of water.

Study groups in NCT00513279
Study groupRoleWhat they receive
Cohort 1ExperimentalSubjects in Cohort 1 will be randomized to one of the following sequences: ABDFH, BADFH, BDAFH, BDFAH and BDFHA in a 1:1:1:1:1 ratio where A = Placebo, B= GSK618334 dose 1 (2.5 mg), D = GSK618334 dose 3, F = GSK618334 dose 5, H = GSK618334 dose 7. On day 1, subjects will be administered a starting dose of 2.5 milligrams (mg) GSK618334. The planned doses of GSK618334 to be administered in Cohort 1 are 2.5, 25, 100 and 400mg. In each dosing period 2 subjects will receive placebo and 8 subjects will receive GSK618334. Subjects within a cohort will have a washout period of at least two weeks from last dose before receiving another dose.
Receives: Drug: GSK618334; Drug: GSK618334 matching placebo tablets
Cohort 2ExperimentalSubjects in Cohort 2 will be randomized to one of the following sequences: ACEGI, CAEGI, CEAGI, CEGAI, CEGIA in a 1:1:1:1:1 ratio where A = Placebo, C= GSK618334 dose 2, E = GSK618334dose 4, G = GSK618334 dose 6, I= GSK618334 dose 8. In each dosing period 2 subjects will receive placebo and 8 subjects will receive GSK618334. Subjects within a cohort will have a washout period of at least two weeks from last dose before receiving another dose.
Receives: Drug: GSK618334; Drug: GSK618334 matching placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety measures: ECG, Vital Signs, Adverse Events

    Measured: for 48 hours after dosing.

  2. PK measures: Blood sampling for GSK598809

    Measured: for up to 96hr post dose

Secondary outcomes (5)

  1. Tests on cognition (thinking)

    Measured: for 48 hours after dosing

  2. Movement rating scales

    Measured: pre-dose, 2, 4 and 24 hours post-dose on Day 1

  3. Prolactin, TSH and GH

    Measured: pre-dose, 1, 2, 4, 8 and 24 hours post-dose on Day 1

  4. Psychological assessments

    Measured: pre-dose, up to 48 hours post-dose

  5. Cognitive/Impulsivity tests

    Measured: pre-dose, 2, 7 and 24 hours post-dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2007 (estimated)
  2. Study start28 Jun 2007
  3. Primary completion4 Oct 2007
  4. Study completion4 Oct 2007

Resources

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
Crossover
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513279
Sponsor's protocol ID
DBU107640
Status last verified
Sep 2017
First submitted
6 Aug 2007
Last updated
15 Sep 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK618334 in people with Substance Dependence, run by GlaxoSmithKline 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 5 inclusion and 20 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 15 Sep 2017. 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?

Safety measures: ECG, Vital Signs, Adverse Events (time frame: for 48 hours after dosing.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00513279.

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 15 Sep 2017.

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