Substance DependencePhase 1NCT00437840
A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809
A Phase 1 study testing GSK598809 in people with Substance Dependence, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels of GSK598809 and nicotine. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Dependence
- What is being tested?
- GSK598809
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2007to 20 Jun 2007
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male smoker between the ages of 18 and 50 years
- Body weight greater than 50kg and BMI between 18.5-29.9 kg/m2.
- No abnormalities on the medical, psychiatric or laboratory evaluation
- Smoke on average more than 20 but less that 40 cigarettes per day for the past year and not tried to give up in the 3 months before the study.
Who cannot join
- History of psychiatric disorder or sleep disorder.
- Receiving treatment for smoking cessation.
- Use tobacco products other than cigarettes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses of GSK598809 in Smokers
GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels of GSK598809 and nicotine.
- Conditions
- Substance Dependence
- Being tested
- GSK598809, Placebo
- Keywords
- healthy volunteers,, tolerability,, pharmacokinetics,, pharmacodynamics, safety,, smoking,
- Medical subject headings
- Substance-Related Disorders, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK598809Drug
GSK598809 capsules will be available in dose strength of 5 and 25 mg. Subjects will receive single oral dose of GSK598809 n order to achieve the required dose.
PlaceboDrug
Subjects will receive single oral dose of matching placebo tablet to GSK598809.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | In Arm A dosing subject will receive Placebo in Week 1, 10 milligram (mg) of GSK598809 in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. Receives: Drug: GSK598809; Drug: Placebo |
| Treatment Arm B | Experimental | In Arm B dosing subject will receive 10 mg of GSK598809 in Week 1, Placebo in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. Receives: Drug: GSK598809; Drug: Placebo |
| Treatment Arm C | Experimental | In Arm C dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, Placebo in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. Receives: Drug: GSK598809; Drug: Placebo |
| Treatment Arm D | Experimental | In Arm D dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, 75 mg of GSK598809 in Week 3, Placebo in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. Receives: Drug: GSK598809; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures: ECG, Vital Signs, Adverse Events
Measured: for 48 hours after dosing.
PK: Blood levels of GSK598809 and nicotine
Measured: for 96 hours after dosing
Secondary outcomes (2)
Questionnaires on nicotine craving
Measured: for 24 hours after dosing
Tests on cognition (thinking)
Measured: for 48 hours after dosing
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 start20 Mar 2007
- Primary completion20 Jun 2007
- Study completion20 Jun 2007
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
- Single group
- Enrolment
- 12 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
- NCT00437840
- Sponsor's protocol ID
- DAN107606
- Status last verified
- Aug 2017
- First submitted
- 20 Feb 2007
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses of GSK598809 in Smokers
- ClinicalTrials.gov ID
- NCT00437840
- Acronym / sponsor ID
- DAN107606
- Conditions
- Substance Dependence
- Keywords
- healthy volunteers,, tolerability,, pharmacokinetics,, pharmacodynamics, safety,, smoking,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2007 (actual)
- Primary completion
- 20 Jun 2007 (actual)
- Study completion
- 20 Jun 2007 (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 to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels of GSK598809 and nicotine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: GSK598809, Drug: PlaceboIn Arm A dosing subject will receive Placebo in Week 1, 10 milligram (mg) of GSK598809 in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. |
| Treatment Arm B | Experimental | Drug: GSK598809, Drug: PlaceboIn Arm B dosing subject will receive 10 mg of GSK598809 in Week 1, Placebo in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. |
| Treatment Arm C | Experimental | Drug: GSK598809, Drug: PlaceboIn Arm C dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, Placebo in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. |
| Treatment Arm D | Experimental | Drug: GSK598809, Drug: PlaceboIn Arm D dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, 75 mg of GSK598809 in Week 3, Placebo in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male smoker between the ages of 18 and 50 years
- Body weight greater than 50kg and BMI between 18.5-29.9 kg/m2.
- No abnormalities on the medical, psychiatric or laboratory evaluation
- Smoke on average more than 20 but less that 40 cigarettes per day for the past year and not tried to give up in the 3 months before the study.
Key exclusion criteria (3 listed)
- History of psychiatric disorder or sleep disorder.
- Receiving treatment for smoking cessation.
- Use tobacco products other than cigarettes.
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 |
|---|---|---|
| GSK598809GSK598809 capsules will be available in dose strength of 5 and 25 mg. Subjects will receive single oral dose of GSK598809 n order to achieve the required dose. | Drug | Treatment Arm A, Treatment Arm B, Treatment Arm C, Treatment Arm D |
| PlaceboSubjects will receive single oral dose of matching placebo tablet to GSK598809. | Drug | Treatment Arm A, Treatment Arm B, Treatment Arm C, Treatment Arm D |
Primary outcome
Safety measures: ECG, Vital Signs, Adverse Events
Time frame: for 48 hours after dosing.
PK: Blood levels of GSK598809 and nicotine
Time frame: for 96 hours after dosing
2 secondary outcomes
Questionnaires on nicotine craving
Time frame: for 24 hours after dosing
Tests on cognition (thinking)
Time frame: for 48 hours after dosing
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 7 Aug 2017.
- Results for study DAN107606 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 in people with Substance Dependence, run by GlaxoSmithKline at 1 site in Germany.
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 4 inclusion and 3 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 7 Aug 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 Germany. 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 (time frame: for 48 hours after dosing.). The study lists 2 primary outcomes in all. 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 7 Aug 2017.