Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A placebo-controlled, single blind, randomized two part study toinvestigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers.
Trial description: The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels.
Timeframe: First dose to follow-up
To assess blood concentrations of GSK618334 after repeated oral doses.
Timeframe: First dose to 72 hours post last dose
Secondary outcomes:
To assess the effect of food on GSK618334 blood concentrations after a single dose.
Timeframe: First dose of the single dose session to 24 hours after dosing of the repeat dose session
The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.
Timeframe: First dose to 24 hours after last dose
Interventions:
Drug: GSK618334 Low Dose
Drug: GSK618334 PET subjects
Drug: GSK618334 Medium Dose
Drug: GSK618334 High Dose
Enrollment:
46
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)
September 2009 to February 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- Healthy Males and Females between the ages of 18-50 years old
- Male and Female subjects must agree to use protocol specified contraceptive methods.
- A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
- Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy Males and Females between the ages of 18-50 years old
- Male and Female subjects must agree to use protocol specified contraceptive methods.
- Male subjects only in PET parts of the study.
- Capable of providing written informed consent.
Exclusion criteria:
- A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
- Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
- Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
- Screening ECG parameters outside the protocol specified parameters.
- Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <95 mmHg OR a diastolic blood pressure >90 or <50 mmHg at screening and/or baseline.
- Pregnant or lactating females.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
- Significant suicidal risk.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
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
2010-17-02
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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