Last updated: 11/04/2018 06:10:08

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

GSK study ID
DBU107640
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Safety measures: ECG, Vital Signs, Adverse Events

Timeframe: for 48 hours after dosing.

PK measures: Blood sampling for GSK598809

Timeframe: for up to 96hr post dose

Secondary outcomes:

Tests on cognition (thinking)

Timeframe: for 48 hours after dosing

Movement rating scales

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

Prolactin, TSH and GH

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

Psychological assessments

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

Cognitive/Impulsivity tests

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

Interventions:
Drug: GSK618334
Drug: GSK618334 matching placebo tablets
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Substance Dependence
Product
GSK618334
Collaborators
Not applicable
Study date(s)
June 2007 to October 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • 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.
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA13UJ
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-04-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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