ObesityPhase 1NCT00976105
Effects of Repeat Dosing of GSK1521498
A Phase 1 study of Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The overall purpose of this study is to see whether the drug is safe and well tolerated when given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of people will be given the drug at variable strengths. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2009to 9 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician
- Non smoking male or female between 18 and 60 years of age inclusive
- A female subject of child-bearing potential must use a contraception method listed in the protocol prior to the start of dosing until at least 14 days after receiving the last dose of study medication.
- Male subjects must agree to use one of the contraception methods listed in the protocol from the first dose of study medication until at least 84 days after receiving the last dose of study medication.
- BMI within the range 25 - 35 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec.
- Suitable for repeat cannulation.
Who cannot join
- Has clinically significant rhythm abnormalities identified during 24-hour screening Holter assessment.
- Systolic blood pressure greater than 150 mmHg and/or diastolic BP greater than 90 mmHg.
- Diabetes mellitus or physician-diagnosed dyslipidaemia requiring treatment
- Self-administered Beck Depression Inventory II scale total score greater than 13 or suicide question score greater than zero at screening.
- Positive pre-study drug/alcohol screen
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Show all 20Show fewer
- Positive test for HIV antibody.
- Pregnant or lactating females
- Smoking history that includes regular use of tobacco or nicotine-containing products within 6 months prior to screening.
- A history of any thyroid dysfunction or an abnormal thyroid function test
- History of regular high level of alcohol consumption within 6 months of the study
- Participated in a clinical trial involving an investigational product within 90 days
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to the first dose of study medication
- History of any gastrointestinal or hepatic conditions or procedures that could affect absorption of the investigational product.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that contraindicates participation.
- 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, including abstaining from consumption of caffeine-or xanthine containing products for 24 hours prior to dosing until the post-dose assessment, use of illicit drugs, refrain from alcohol for 24 hours prior to dosing until final post-dose assessment,, consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until after collection of the final pharmacokinetic blood sample.
- Any finding that would preclude safe use of Echo MRI scanning. These include: a history of panic attacks and/or claustrophobia, pacemaker, implanted hearing aid, metallic body piercing and/or other metal implants that cannot be removed, the opinion of the Investigator the subject exceeds size limitations for the instrument.
- Mentally or legally incapacitated
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of 10 Days of Repeat Dosing of GSK1521498 in Overweight or Obese But Otherwise Healthy Subjects.
The overall purpose of this study is to see whether the drug is safe and well tolerated when given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of people will be given the drug at variable strengths. The blood levels of the drug will be measured and the effects on mood and cognition (the mental processes involved in awareness, learning and judgement) will be assesed.
Read the detailed description
This study is to test a new drug which may be used for treating eating behaviour and patterns that some overweight and obese patients find difficult to control. The drug works by inhibiting the effects of messenger molecules called opioids, e.g. endorphins. These opioids are naturally produced within the human body and control hunger, thirst, and the pleasurable feelings we relate to eating food. The drug attaches to opioid binding sites in the brain, known as mu-opioid receptors; this blocks the natural effect of opioids which may reduce the craving to eat fatty or sugary foods. Single doses of the drug have been given to humans and showed it was safe. Now the drug will be given every day for 10 days to check that the drug is safe and tolerated when given repeatedly. The study is in two parts:
Part A: people will receive a sleeping tablet to make them sleepy (or a dummy drug) and will complete some questionnaires and simple tests including computer exercises to test the effect of this tablet on mood and cognition. This information will be used to help judge what is happening in Part B.
Part B: requires staying in the unit for 10 days to receive a tablet every day and complete questionnaires and other tests to check for any mood and cognitive changes. Various other assessments will include effects on eating behaviour, pain measures and changes in body composition (content of fat, muscle and water).
- Conditions
- Obesity
- Being tested
- Zolpidem or placebo - Hypnotic drug given for sleep disorders, GSK1521498 or placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety and tolerability, Repeat dose, Personality traits, Fat mass, Healthy volunteers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem or placebo - Hypnotic drug given for sleep disordersDrug
The information gathered from Part A will be used as a benchmark against which any effects of GSK1521498 can be assessed in Part B.
GSK1521498 or placeboDrug
The first group will start at a low dose (10 mg GSK1521498 or placebo) for 10 days. The study team will then assess the data gathered from the first cohort and will select the dose that the next cohort will receive for 10 days. There will be up to 4 cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Zolpidem or placebo | Active comparator | This part is designed to examine the acute effects of up to 10mg of a known hypnotic sedative drug (Zolpidem) on cognitive and mood changes sensitve to sedation and tiredess. Receives: Drug: Zolpidem or placebo - Hypnotic drug given for sleep disorders |
| Part B: GSK1521498 or placebo | Experimental | At least 15 hours after Part A is completed subjects will enter Part B of the study. Receives: Drug: GSK1521498 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: adverse events, blood pressure, heart rate, ECG, clinical chemistry, heamatology, urinalysis, change in reaction times, change in mood scales
Measured: During 10 days of repeat dosing
Obtain benchmarking data on the cognitive and mood changes induced by a single dose of up to 10mg zolpidem
Measured: Single occasion
Secondary outcomes (3)
Assess accumulation, dose proportionality and pharmacokinetics of GSK1521498: AUC (0-24), Cmax, tmax, tlag (Dose 1 only), t1/2 (Dose 10 only), trough plasma concentrations on Day 5, 7, 8, 9 and 10
Measured: On Day 1 and/or following 10 days of repeat dosing and trough samples on Day 5, 7, 8, 9 and 10
PK/PD relationships: cognitive and mood changes, pressure pain threshold and tolerance, heat pain threshold
Measured: During 10 days of reapeat dosing
Assess effects on body weight, fat mass, eating behaviour and personality traits: Bodyweight and BMI, Fat mass (ECHO-MRI), food ingested and energy intake, eating behaviour and persoality scales: Y-BOC-BE, BE, TFEQ and BIS
Measured: Screening, or Day -1 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study start22 Sep 2009
- Primary completion9 Mar 2010
- Study completion9 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 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
- NCT00976105
- Sponsor's protocol ID
- 111849
- Status last verified
- Jun 2017
- First submitted
- 11 Sep 2009
- Last updated
- 20 Jun 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 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of 10 Days of Repeat Dosing of GSK1521498 in Overweight or Obese But Otherwise Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00976105
- Acronym / sponsor ID
- 111849
- Conditions
- Obesity
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety and tolerability, Repeat dose, Personality traits, Fat mass, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2009 (actual)
- Primary completion
- 9 Mar 2010 (actual)
- Study completion
- 9 Mar 2010 (actual)
- First posted
- 14 Sep 2009 (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 overall purpose of this study is to see whether the drug is safe and well tolerated when given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of people will be given the drug at variable strengths. The blood levels of the drug will be measured and the effects on mood and cognition (the mental processes involved in awareness, learning and judgement) will be assesed.
Detailed description
This study is to test a new drug which may be used for treating eating behaviour and patterns that some overweight and obese patients find difficult to control. The drug works by inhibiting the effects of messenger molecules called opioids, e.g. endorphins. These opioids are naturally produced within the human body and control hunger, thirst, and the pleasurable feelings we relate to eating food. The drug attaches to opioid binding sites in the brain, known as mu-opioid receptors; this blocks the natural effect of opioids which may reduce the craving to eat fatty or sugary foods. Single doses of the drug have been given to humans and showed it was safe. Now the drug will be given every day for 10 days to check that the drug is safe and tolerated when given repeatedly. The study is in two parts:
Part A: people will receive a sleeping tablet to make them sleepy (or a dummy drug) and will complete some questionnaires and simple tests including computer exercises to test the effect of this tablet on mood and cognition. This information will be used to help judge what is happening in Part B.
Part B: requires staying in the unit for 10 days to receive a tablet every day and complete questionnaires and other tests to check for any mood and cognitive changes. Various other assessments will include effects on eating behaviour, pain measures and changes in body composition (content of fat, muscle and water).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Zolpidem or placebo | Active comparator | Drug: Zolpidem or placebo - Hypnotic drug given for sleep disordersThis part is designed to examine the acute effects of up to 10mg of a known hypnotic sedative drug (Zolpidem) on cognitive and mood changes sensitve to sedation and tiredess. |
| Part B: GSK1521498 or placebo | Experimental | Drug: GSK1521498 or placeboAt least 15 hours after Part A is completed subjects will enter Part B of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy as determined by a responsible and experienced physician
- Non smoking male or female between 18 and 60 years of age inclusive
- A female subject of child-bearing potential must use a contraception method listed in the protocol prior to the start of dosing until at least 14 days after receiving the last dose of study medication.
- Male subjects must agree to use one of the contraception methods listed in the protocol from the first dose of study medication until at least 84 days after receiving the last dose of study medication.
- BMI within the range 25 - 35 kg/m2 (inclusive).
Key exclusion criteria (20 listed)
- Has clinically significant rhythm abnormalities identified during 24-hour screening Holter assessment.
- Systolic blood pressure greater than 150 mmHg and/or diastolic BP greater than 90 mmHg.
- Diabetes mellitus or physician-diagnosed dyslipidaemia requiring treatment
- Self-administered Beck Depression Inventory II scale total score greater than 13 or suicide question score greater than zero at screening.
- Positive pre-study drug/alcohol screen
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 |
|---|---|---|
| Zolpidem or placebo - Hypnotic drug given for sleep disordersThe information gathered from Part A will be used as a benchmark against which any effects of GSK1521498 can be assessed in Part B. | Drug | Part A: Zolpidem or placebo |
| GSK1521498 or placeboThe first group will start at a low dose (10 mg GSK1521498 or placebo) for 10 days. The study team will then assess the data gathered from the first cohort and will select the dose that the next cohort will receive for 10 days. There will be up to 4 cohorts. | Drug | Part B: GSK1521498 or placebo |
Primary outcome
Safety and tolerability: adverse events, blood pressure, heart rate, ECG, clinical chemistry, heamatology, urinalysis, change in reaction times, change in mood scales
Time frame: During 10 days of repeat dosing
Obtain benchmarking data on the cognitive and mood changes induced by a single dose of up to 10mg zolpidem
Time frame: Single occasion
3 secondary outcomes
Assess accumulation, dose proportionality and pharmacokinetics of GSK1521498: AUC (0-24), Cmax, tmax, tlag (Dose 1 only), t1/2 (Dose 10 only), trough plasma concentrations on Day 5, 7, 8, 9 and 10
Time frame: On Day 1 and/or following 10 days of repeat dosing and trough samples on Day 5, 7, 8, 9 and 10
PK/PD relationships: cognitive and mood changes, pressure pain threshold and tolerance, heat pain threshold
Time frame: During 10 days of reapeat dosing
Assess effects on body weight, fat mass, eating behaviour and personality traits: Bodyweight and BMI, Fat mass (ECHO-MRI), food ingested and energy intake, eating behaviour and persoality scales: Y-BOC-BE, BE, TFEQ and BIS
Time frame: Screening, or Day -1 and Day 10
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 20 Jun 2017.
- 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.
- Results for study 111849 can be found on the GSK Clinical Study Register.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.
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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 of Obesity, 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 8 inclusion and 20 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 20 Jun 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 and tolerability: adverse events, blood pressure, heart rate, ECG, clinical chemistry, heamatology, urinalysis, change in reaction times, change in mood scales (time frame: During 10 days of repeat 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 20 Jun 2017.