Substance DependencePhase 1NCT00728052
A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers
A Phase 1 study testing GSK598809 in people with Substance Dependence, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jun 2008to 19 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
- A healthy man or woman
- 18 - 50 years old
- Neither too fat, nor too thin
- Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.
- Female subjects must not be breast feeding and should not have been breast feeding for a month.
- Male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up.
- Subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study.
Who cannot join
- Any current medical or psychiatric illness
- Any history of chronic medical or psychiatric illnesses
- Previous or current alcohol or drug abuse/dependence including nicotine
- Personal or family history of prolonged QTc syndrome
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 (75mg and Above) of GSK598809 in Otherwise Healthy Smokers
Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.
- Conditions
- Substance Dependence
- Being tested
- GSK598809, Placebo
- Keywords
- Tolerability, dose escalation, GSK598809, Pharmacodynamics, Safety, single, placebo, Smokers, 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
GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
PlaceboDrug
Placebo capsules will be administered orally with water.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence ABCD | Experimental | Subjects will receive treatment sequence ABCD; A= placebo, B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, and D = GSK598809 dose 3. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects receiving treatment sequence BACD | Experimental | Subjects will receive treatment sequence BACD; B= GSK598809 dose 1 (75 milligrams), A= placebo, C = GSK598809 dose 2 and D = GSK598809 dose 3 Receives: Drug: GSK598809; Drug: Placebo |
| Subjects receiving treatment sequence BCAD | Experimental | Subjects will receive treatment sequence BCAD; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, A= placebo and D = GSK598809 dose 3. Receives: Drug: GSK598809; Drug: Placebo |
| Subjects receiving treatment sequence BCDA | Experimental | Subjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo. Receives: Drug: GSK598809; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours.
Measured: 48 hours post dose
Secondary outcomes (1)
Cigarette craving assessed over 24 hours around dosing. Cigarette Consumption to be monitored during the whole study.Withdrawal from nicotine assessed during first four hours of dosing. Cognition/ impulsivity assessed over 24 hours after dosing.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study start9 Jun 2008
- Primary completion19 Aug 2008
- Study completion19 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT00728052
- Sponsor's protocol ID
- DAN111282
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2008
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 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 (75mg and Above) of GSK598809 in Otherwise Healthy Smokers
- ClinicalTrials.gov ID
- NCT00728052
- Acronym / sponsor ID
- DAN111282
- Conditions
- Substance Dependence
- Keywords
- Tolerability, dose escalation, GSK598809, Pharmacodynamics, Safety, single, placebo, Smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2008 (actual)
- Primary completion
- 19 Aug 2008 (actual)
- Study completion
- 19 Aug 2008 (actual)
- First posted
- 5 Aug 2008 (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.
Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment sequence ABCD | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will receive treatment sequence ABCD; A= placebo, B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, and D = GSK598809 dose 3. |
| Subjects receiving treatment sequence BACD | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will receive treatment sequence BACD; B= GSK598809 dose 1 (75 milligrams), A= placebo, C = GSK598809 dose 2 and D = GSK598809 dose 3 |
| Subjects receiving treatment sequence BCAD | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will receive treatment sequence BCAD; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, A= placebo and D = GSK598809 dose 3. |
| Subjects receiving treatment sequence BCDA | Experimental | Drug: GSK598809, Drug: PlaceboSubjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A healthy man or woman
- 18 - 50 years old
- Neither too fat, nor too thin
- Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.
- Female subjects must not be breast feeding and should not have been breast feeding for a month.
Key exclusion criteria (4 listed)
- Any current medical or psychiatric illness
- Any history of chronic medical or psychiatric illnesses
- Previous or current alcohol or drug abuse/dependence including nicotine
- Personal or family history of prolonged QTc syndrome
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 with dose strengths of 5 milligrams and 25 milligrams, administered orally with water. | Drug | Subjects receiving treatment sequence ABCD, Subjects receiving treatment sequence BACD, Subjects receiving treatment sequence BCAD, Subjects receiving treatment sequence BCDA |
| PlaceboPlacebo capsules will be administered orally with water. | Drug | Subjects receiving treatment sequence ABCD, Subjects receiving treatment sequence BACD, Subjects receiving treatment sequence BCAD, Subjects receiving treatment sequence BCDA |
Primary outcome
Safety and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours.
Time frame: 48 hours post dose
1 secondary outcome
Cigarette craving assessed over 24 hours around dosing. Cigarette Consumption to be monitored during the whole study.Withdrawal from nicotine assessed during first four hours of dosing. Cognition/ impulsivity assessed over 24 hours after dosing.
Time frame: 24 hours
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 3 Aug 2017.
- Results for study DAN111282 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 7 inclusion and 4 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 3 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 and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours. (time frame: 48 hours post dose). 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 3 Aug 2017.