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

NCT00513279 | Completed Phase 1

• 1 other identifier: DBU107640
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Dependence

Keywords

Safety,; GSK618334; pharmacokinetics,; repeat dose,; tolerability,; pharmacodynamics,; placebo,

Outcome Measures

Primary Outcomes (2)

• Safety measures: ECG, Vital Signs, Adverse Events

  for 48 hours after dosing.

• PK measures: Blood sampling for GSK598809

  for up to 96hr post dose

Secondary Outcomes (5)

• Tests on cognition (thinking)

  for 48 hours after dosing

• Movement rating scales

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

• Prolactin, TSH and GH

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

• Psychological assessments

  pre-dose, up to 48 hours post-dose

• Cognitive/Impulsivity tests

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

Study Arms (2)

Cohort 1

EXPERIMENTAL

Subjects 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.

Drug: GSK618334; Drug: GSK618334 matching placebo tablets

Cohort 2

EXPERIMENTAL

Subjects 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.

Drug: GSK618334; Drug: GSK618334 matching placebo tablets

Interventions

GSK618334 DRUG

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

Cohort 1; Cohort 2

GSK618334 matching placebo tablets DRUG

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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Harrow, Middlesex, HA13UJ, United Kingdom

Location

Related Links

• Results for study DBU107640 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: June 28, 2007
• Primary Completion: October 4, 2007
• Study Completion: October 4, 2007
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

GB (1)