Substance DependencePhase 1NCT00437632
Study To Investigate If Repeat Doses Of GSK598809 Are Safe And Well Tolerated And To Evaluate Blood Levels Of GSK598809
A Phase 1 study testing GSK598809 and Caffeine in people with Substance Dependence, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Dependence
- What is being tested?
- GSK598809 and Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2007to 22 Aug 2008
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- Semi-supine vital signs at screening outside ranges defined in the protocol:
- Reduction, in systolic blood pressure, at screening, of 20 mm Hg or more on standing (compared with semi-supine measurement).
- Personal or family history of long QT syndrome or other cardiac conduction disorder, or other clinically significant cardiac disease.
- Serum electrolyte concentration outside the reference range.
- The subject has a serum prolactin that exceeds the normal range.
- Inability to abstain from strenuous physical activity for 24 h before screening, follow-up, and each admission to the ward.
- Presence or history of a recognised sleep disorder, or subject complains of sleep disturbances and/or is receiving treatment for sleep disorders, which might (on the basis of medical judgement) affect the pharmacodynamic or safety assessments.
- Inability to be successfully trained in tests of cognition. Additional Criteria for Section 3 only
- Consumption of coffee, cola or other caffeine containing drinks (Caffeine is one of the study substrates) within 4 days preceding the first dose
- Consumption of charcoal-broiled beef or cruciferous vegetables (e.g. broccoli, cabbage, brussel sprouts, cauliflower) within 7 days prior to the first dose . This foodstuff is a known inducer of the CYP1A2 enzyme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Substance Dependence
- Being tested
- GSK598809, Placebo, Caffeine
- Keywords
- repeat dose,, placebo,, Safety,, pharmacodynamics,, tolerability,, GSK598809, pharmacokinetics,
- 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.
GSK598809Drug
Also called GSK598809/Placebo
GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.
PlaceboDrug
Subjects will receive matching placebo capsules to GSK598809 orally with water.
CaffeineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects in Cohort-1 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 10 mg or Placebo. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects in Cohort-2 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 25 mg or Placebo. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects in Cohort-3 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 25 mg or Placebo. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects in Cohort-4 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 40 mg or Placebo. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects in Cohort-5 of Section 2 | Experimental | Subjects 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. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects in Cohort-6 of Section 3 | Experimental | Subjects 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. Receives: Drug: GSK598809; Drug: Placebo; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures: ECG, Vital Signs, Adverse Events for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose
Measured: Up to Day 39
Secondary outcomes (9)
Tests on cognition (thinking) for 24 hours after dosing
Measured: Up to Day 36
Akathisia assessment
Measured: Up to Day 36
Involuntary Movements
Measured: Up to Day 36
Simpson Angus Scale (SAS)
Measured: Up to Day 36
Serum prolactin, GH and thyroid stimulating hormone (TSH), total and free testosterone, LH and FSH concentrations as possible
Measured: Up to Day 39
Psychological assessment
Measured: Up to Day 36
Cognition/impulsivity:
Measured: Up to Day 35
Pharmacokinetics:
Measured: Up to Day 38
GSK685249 levels to derive pharmacokinetic parameter
Measured: Up to Day 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study start1 Mar 2007
- Primary completion22 Aug 2008
- Study completion22 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437632
- Sponsor's protocol ID
- DAN106587
- Status last verified
- Jul 2017
- First submitted
- 19 Feb 2007
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00437632
- Acronym / sponsor ID
- DAN106587
- Conditions
- Substance Dependence
- Keywords
- repeat dose,, placebo,, Safety,, pharmacodynamics,, tolerability,, GSK598809, pharmacokinetics,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 22 Aug 2008 (actual)
- Study completion
- 22 Aug 2008 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects in Cohort-1 of Section 1 | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will be randomized to receive either GSK598809 10 mg or Placebo. |
| Subjects in Cohort-2 of Section 1 | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will be randomized to receive either GSK598809 25 mg or Placebo. |
| Subjects in Cohort-3 of Section 1 | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will be randomized to receive either GSK598809 25 mg or Placebo. |
| Subjects in Cohort-4 of Section 1 | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will be randomized to receive either GSK598809 40 mg or Placebo. |
| Subjects in Cohort-5 of Section 2 | Experimental | Drug: GSK598809, Drug: PlaceboSubjects 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 | Experimental | Drug: GSK598809, Drug: Placebo, Drug: CaffeineSubjects 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK598809Also: GSK598809/PlaceboGSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water. | Drug | Subjects in Cohort-1 of Section 1, Subjects in Cohort-2 of Section 1, Subjects in Cohort-3 of Section 1, Subjects in Cohort-4 of Section 1, Subjects in Cohort-5 of Section 2, Subjects in Cohort-6 of Section 3 |
| PlaceboSubjects will receive matching placebo capsules to GSK598809 orally with water. | Drug | Subjects in Cohort-1 of Section 1, Subjects in Cohort-2 of Section 1, Subjects in Cohort-3 of Section 1, Subjects in Cohort-4 of Section 1, Subjects in Cohort-5 of Section 2, Subjects in Cohort-6 of Section 3 |
| CaffeineCaffeine 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. | Drug | Subjects in Cohort-6 of Section 3 |
Primary outcome
Safety measures: ECG, Vital Signs, Adverse Events for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose
Time frame: Up to Day 39
9 secondary outcomes
Tests on cognition (thinking) for 24 hours after dosing
Time frame: Up to Day 36
Akathisia assessment
Time frame: Up to Day 36
Involuntary Movements
Time frame: Up to Day 36
Simpson Angus Scale (SAS)
Time frame: Up to Day 36
Serum prolactin, GH and thyroid stimulating hormone (TSH), total and free testosterone, LH and FSH concentrations as possible
Time frame: Up to Day 39
Psychological assessment
Time frame: Up to Day 36
Cognition/impulsivity:
Time frame: Up to Day 35
Pharmacokinetics:
Time frame: Up to Day 38
GSK685249 levels to derive pharmacokinetic parameter
Time frame: Up to Day 38
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Results for study DAN106587 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK598809 and Caffeine 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 6 inclusion and 25 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 31 Jul 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 for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose (time frame: Up to Day 39). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2017.