Sleep Initiation and Maintenance DisordersPhase 1NCT00495729
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
A Phase 1 study testing SB-649868 and Simvastatin in people with Sleep Initiation and Maintenance Disorders, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- SB-649868 and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 18 Apr 2007to 4 Aug 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male subjects aged between 18 and 65 years of age inclusive.
- Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Subjects will have blood pressure measurements within the normal range for healthy volunteers.
Who cannot join
- The subject has a positive pre-study urine drug/ alcohol urine screen.
- A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
- Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomised, Placebo-controlled, 15 Day Repeated-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-649868 and Its Interaction With the CYP3A4 Isoenzyme in Healthy Male Subjects.
Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.
- Being tested
- SB-649868, Placebo, Simvastatin
- Keywords
- SB-649868,, Simvastatin, Repeated dose,
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-649868Drug
Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
PlaceboDrug
Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
SimvastatinDrug
Subjects will receive Simvastatin 10 mg tablets orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin. Receives: Drug: SB-649868; Drug: Placebo; Drug: Simvastatin |
| Cohort 2 | Experimental | Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin. Receives: Drug: SB-649868; Drug: Placebo; Drug: Simvastatin |
| Cohort 3 | Experimental | Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin. Receives: Drug: SB-649868; Drug: Placebo; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
-AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)
Measured: after the SD and 14 days RD period (15 days)
- SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)
Measured: on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)
- Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15
Measured: on days -10,1,4,7 and 15
Secondary outcomes (1)
Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.
Measured: on days -7, 7 and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study start18 Apr 2007
- Primary completion4 Aug 2007
- Study completion4 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- 36 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
- NCT00495729
- Sponsor's protocol ID
- OXS104092
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomised, Placebo-controlled, 15 Day Repeated-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-649868 and Its Interaction With the CYP3A4 Isoenzyme in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT00495729
- Acronym / sponsor ID
- OXS104092
- Keywords
- SB-649868,, Simvastatin, Repeated dose,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2007 (actual)
- Primary completion
- 4 Aug 2007 (actual)
- Study completion
- 4 Aug 2007 (actual)
- First posted
- 3 Jul 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.
Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SB-649868, Drug: Placebo, Drug: SimvastatinSubjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin. |
| Cohort 2 | Experimental | Drug: SB-649868, Drug: Placebo, Drug: SimvastatinSubjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin. |
| Cohort 3 | Experimental | Drug: SB-649868, Drug: Placebo, Drug: SimvastatinSubjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult male subjects aged between 18 and 65 years of age inclusive.
- Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Subjects will have blood pressure measurements within the normal range for healthy volunteers.
Key exclusion criteria (4 listed)
- The subject has a positive pre-study urine drug/ alcohol urine screen.
- A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
- Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.
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 |
|---|---|---|
| SB-649868Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboSubjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| SimvastatinSubjects will receive Simvastatin 10 mg tablets orally. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
-AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)
Time frame: after the SD and 14 days RD period (15 days)
- SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)
Time frame: on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)
- Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15
Time frame: on days -10,1,4,7 and 15
1 secondary outcome
Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.
Time frame: on days -7, 7 and 14.
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 8 Aug 2017.
- Results for study OXS104092 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 SB-649868 and Simvastatin in people with Sleep Initiation and Maintenance Disorders, 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 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 8 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?
-AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days) (time frame: after the SD and 14 days RD period (15 days)). The study lists 3 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 8 Aug 2017; AzTrials last refreshed its copy on 4 Nov 2026.