Sleep DisordersPhase 1NCT01299597
A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.
A Phase 1 study testing Atorvastatin, Simvastatin and SB649868 in people with Sleep Disorders, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868. 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 Disorders
- What is being tested?
- Atorvastatin, Simvastatin and SB649868
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2010to 26 Feb 2010
- 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 male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However,
- Subjects with cTpn I values above 99th percentile of normal range of the selected assay should always be excluded from enrollment;
- Subjects with alkaline phosphatase or bilirubin > 1.5xULN should always be excluded (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
- Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 days post last dose (equivalent to 5 terminal half-lives post-last dose).
- Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism. pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subjects, who in the Investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
- History of cardiovascular diseases and/or evidence of repolarization defects.
- Family history of heriditary muscular disorders.
- Subjects with abnormal ECG defined as: average QTcB or QTcF > 450 msec; PQ < 120 ms or > 220 ms; complete left bundle branch block; second-or third-degree AV block; any relevant ST/T wave abnormalities ; any atrial or ventricular arrhtymias which are of clinical significance as determined by the Investigator.
- History of regular alcohol consumption within 6 months of the study defined as:
Show all 21Show fewer
- an average weekly intake of greater than 21 units (14 units for female) or an average daily intake of greater than 3 units (2 units for female). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody.
- A positive pre-study drug/alcohol screen.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Use of prescription or non-prescription drugs, including 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) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Consumption of broccoli, radish sprouts, cauliflower, cabbage, orange juice, apple juice grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood sample.
- The subject has participated in a clinical trial and has received an investigational product (IP) within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
- Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
- Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868.
- Conditions
- Sleep Disorders
- Being tested
- Atorvastatin, Simvastatin, SB649868
- Keywords
- repeat dose, statins, safety and tolerability, drug interaction, sb649868, healthy male subjects, pharmacokinetics
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period.
SimvastatinDrug
10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period.
SB649868Drug
20mg daily given for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Atorvastatin | Experimental | single dose session with Atorvastatin with PK samples collected up to 72h post dose, then 14 days repeat dose session with SB649868 with Atorvastatin single dose co-administered on day 8 (same time as SB649868) and on day 12 (2 hours before SB649868). Receives: Drug: Atorvastatin; Drug: SB649868 |
| Cohort 2: Simvastatin | Experimental | single dose session with Simvastatin with PK samples collected up to 24h post dose, then 14 days repeat dose session with SB649868 with Simvastatin single dose co-administered on day 12 (same time as SB649868) and on day 14 (2 hours before SB649868). Receives: Drug: Simvastatin; Drug: SB649868 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability evaluated by adverse event monitoring, ECG, Vital Signs, physical examination, laboratory values and Romberg/heel to toe tests; plasma analysis of Simvastatin and Atorvastatin and active metabolites.
Measured: screening period of 28 days followed 17 days clinical duration plus a follow up visit 7-14 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study start18 Jan 2010
- Primary completion26 Feb 2010
- Study completion26 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01299597
- Sponsor's protocol ID
- 109652
- Status last verified
- Jul 2017
- First submitted
- 1 Jul 2010
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT01299597
- Acronym / sponsor ID
- 109652
- Conditions
- Sleep Disorders
- Keywords
- repeat dose, statins, safety and tolerability, drug interaction, sb649868, healthy male subjects, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2010 (actual)
- Primary completion
- 26 Feb 2010 (actual)
- Study completion
- 26 Feb 2010 (actual)
- First posted
- 18 Feb 2011 (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.
The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Atorvastatin | Experimental | Drug: Atorvastatin, Drug: SB649868single dose session with Atorvastatin with PK samples collected up to 72h post dose, then 14 days repeat dose session with SB649868 with Atorvastatin single dose co-administered on day 8 (same time as SB649868) and on day 12 (2 hours before SB649868). |
| Cohort 2: Simvastatin | Experimental | Drug: Simvastatin, Drug: SB649868single dose session with Simvastatin with PK samples collected up to 24h post dose, then 14 days repeat dose session with SB649868 with Simvastatin single dose co-administered on day 12 (same time as SB649868) and on day 14 (2 hours before SB649868). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However,
- Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
- Subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 days post last dose (equivalent to 5 terminal half-lives post-last dose).
- Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (21 listed)
- History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism. pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subjects, who in the Investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
- History of cardiovascular diseases and/or evidence of repolarization defects.
- Family history of heriditary muscular disorders.
- Subjects with abnormal ECG defined as: average QTcB or QTcF > 450 msec; PQ < 120 ms or > 220 ms; complete left bundle branch block; second-or third-degree AV block; any relevant ST/T wave abnormalities ; any atrial or ventricular arrhtymias which are of clinical significance as determined by the Investigator.
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 |
|---|---|---|
| Atorvastatin20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period. | Drug | Cohort 1: Atorvastatin |
| Simvastatin10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period. | Drug | Cohort 2: Simvastatin |
| SB64986820mg daily given for 14 days. | Drug | Cohort 1: Atorvastatin, Cohort 2: Simvastatin |
Primary outcome
Safety and tolerability evaluated by adverse event monitoring, ECG, Vital Signs, physical examination, laboratory values and Romberg/heel to toe tests; plasma analysis of Simvastatin and Atorvastatin and active metabolites.
Time frame: screening period of 28 days followed 17 days clinical duration plus a follow up visit 7-14 days post last dose
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 21 Jul 2017.
- Results for study 109652 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Sleep Disorders
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
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 Atorvastatin, Simvastatin and SB649868 in people with Sleep 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 7 inclusion and 21 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 21 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 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 evaluated by adverse event monitoring, ECG, Vital Signs, physical examination, laboratory values and Romberg/heel to toe tests; plasma analysis of Simvastatin and Atorvastatin and active metabolites. (time frame: screening period of 28 days followed 17 days clinical duration plus a follow up visit 7-14 days post last 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 21 Jul 2017.