Study To Investigate If Repeat Doses Of GSK598809 Are Safe And Well Tolerated And To Evaluate Blood Levels Of GSK598809
A Placebo Controlled, Single Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses of GSK598809 in Healthy Male and Female Volunteers for 28 Days.
1 other identifier
interventional
104
1 country
1
Brief Summary
GSK598809 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 repeat doses of GSK598809 in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2008
CompletedJuly 31, 2017
July 1, 2017
1.5 years
February 19, 2007
July 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety measures: ECG, Vital Signs, Adverse Events for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose
Up to Day 39
Secondary Outcomes (9)
Tests on cognition (thinking) for 24 hours after dosing
Up to Day 36
Akathisia assessment
Up to Day 36
Involuntary Movements
Up to Day 36
Simpson Angus Scale (SAS)
Up to Day 36
Serum prolactin, GH and thyroid stimulating hormone (TSH), total and free testosterone, LH and FSH concentrations as possible
Up to Day 39
- +4 more secondary outcomes
Study Arms (6)
Subjects in Cohort-1 of Section 1
EXPERIMENTALSubjects will be randomized to receive either GSK598809 10 mg or Placebo.
Subjects in Cohort-2 of Section 1
EXPERIMENTALSubjects will be randomized to receive either GSK598809 25 mg or Placebo.
Subjects in Cohort-3 of Section 1
EXPERIMENTALSubjects will be randomized to receive either GSK598809 25 mg or Placebo.
Subjects in Cohort-4 of Section 1
EXPERIMENTALSubjects will be randomized to receive either GSK598809 40 mg or Placebo.
Subjects in Cohort-5 of Section 2
EXPERIMENTALSubjects will be randomized to receive either ascending doses of GSK598809 75, 120 and 175 mg or Placebo. There will be a washout period of 6 days between the doses.
Subjects in Cohort-6 of Section 3
EXPERIMENTALSubjects will receive caffeine on day -1 and after randomization subject will either receive GSK598809 or Placebo on Day 1. After washout period of 1-week subject will either receive GSK598809 or Placebo for 28 days.
Interventions
GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.
Subjects will receive matching placebo capsules to GSK598809 orally with water.
Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
Eligibility Criteria
You may qualify if:
- Healthy adult male or female subject, aged 18-50 years inclusive.
- A female subject is eligible to participate if she is of Non-childbearing potential or Child-bearing potential and agrees to use adequate contraceptive methods until 90 days post-last dose.
- Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Healthy as judged by the responsible physician. No clinically significant abnormality in the medical, psychiatric or laboratory evaluation, including 12-lead ECG and 24-h Holter ECG.
- Signed and dated written informed consent before admission to the study.
- The subject is able to understand and comply with the Investigator's instructions and the requirements and restrictions of the protocol
You may not qualify if:
- The subject has a positive pre-study breath test for alcohol or smoking, or a positive urine drug screen. Drugs that will be screened for are amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines, PCP and cotinine.
- A positive result for Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 at the screening visit.
- Abuse of alcohol, defined as an average weekly intake of more than 28 units (males) or 21 units (females), or an average daily intake of more than 4 units. 1 unit is equivalent to half a pint (285 mL) of beer, 1 measure (25 mL) of spirits, or 1 glass (125 mL) of wine.
- Liver function tests (LFT) that are above the reference range at screening and that remain elevated when repeated (to be discussed with the sponsor, if necessary).
- Consumption of grapefruit juice or grapefruit within 7 days before the first dose of study medication and until collection of the final blood sample for pharmacokinetic analysis.
- Subject is not willing to eat the standard meals provided by the CPRU.
- Participation in other clinical trials of a new chemical entity or a prescription medicine, within the previous 3 months.
- Use of prescription or non-prescription medicines, 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) before 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 400 mL blood during the 3 months before the study, e.g. as a blood donor.
- History or presence of allergy to the study drug or drugs of this class, or a history of any other allergy that, in the opinion of the responsible physician, contraindicates the subject's participation.
- Regular use of tobacco- or nicotine-containing products within 6 months of the start of the study.
- Male subject does not agree to use a condom and spermicide during sexual intercourse with pregnant or lactating females; or if engaging in sexual intercourse with a female partner who could become pregnant. It is strongly recommended that in addition to this the female also uses another form of contraception. This criterion must be followed from the time of the first dose of study medication until 90 days after the last dose of study medication.
- History of a psychiatric diagnosis Axis I or Axis II (DSMIV), or presence of a current psychiatric diagnosis based upon psychiatric evaluation.
- History or presence of respiratory illnesses, gastrointestinal, hepatic or renal disease, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Screening ECG with a QTc interval of \>450 msec and/or a PR interval outside the range 120-220 msec inclusive, or an ECG that is not suitable for QT measurements
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
London, NW10 7NS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2007
First Posted
February 21, 2007
Study Start
March 1, 2007
Primary Completion
August 22, 2008
Study Completion
August 22, 2008
Last Updated
July 31, 2017
Record last verified: 2017-07