DyslipidaemiasPhase 1NCT00783549
A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.
A Phase 1 study testing an undetermined dose of GSK1292263 and ascending dose of GSK1292263 in people with Dyslipidaemias, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidaemias
- What is being tested?
- an undetermined dose of GSK1292263 and ascending dose of GSK1292263
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2008to 31 Mar 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male or female between 18 and 55 years of age
- A female subject is eligible to participate if she is of non-childbearing potential
- Male subjects must agree to use one of the contraception methods listed in the protocol
- BMI within the range 20 - 29.9 kg/m2
- Capable of giving written informed consent, which includes compliance with protocol
- QTcB or QTcF < 450msec.
Who cannot join
- The subject has a positive pre-study drug/alcohol screen
- Positive urinary cotinine levels or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- History of regular alcohol consumption within 6 months of the study
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Unable or unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level.
- Use of illicit drugs.
Show all 33Show fewer
- Use of alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level.
- Consumption of red wine, oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacodynamic blood samples
- 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
- Pregnant females as determined by positive urine hCG test at screening or prior to dosing
- Lactating females
- Has a fasting triglyceride level >400mg/dL (4.45mmol/L)
- Has anemia defined by hemoglobin concentration <11.0g/dL for males or <10.0g/dL for females.
- CPK values higher than 2.5 times the upper limit of normal at screening.
- Significant ECG abnormalities
- abnormal vital signs as defined in the
- History of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound.
- Family history (first or second degree relatives) with a history of hypertrophic cardiomyopathy.
- Family history of torsade de pointes or other ventricular arrhythmias.
- Family history of unexplained sudden death.
- Evidence of early depolarization (e.g., Wolf-Parkinson-White syndrome).
- Has clinically significant rhythm abnormalities identified during 24-hour Screening Holter assessment.
- Subjects who have asthma or a history of asthma
- The subject has participated in a clinical trial and has received an investigational product within a protocol defined period
- 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 within 7 days or 14 days if the drug is a potential enzyme inducer or 5 half-lives 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.
- 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
- Subjects who are taking low-dose aspirin for cardiovascular prophylaxis (81mg or less) are eligible to participate in the study, but the aspirin must be discontinued from Screening to the Follow-up visit
- 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.
- As a result of the medical interview, physical examination, or screening investigations, the investigator considers the subject unfit for the study.
- Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Minneapolis, Minnesota, 55404
About this study
Official title: A Study in Healthy Volunteers of Single Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Compound Alone and When Co-administered With Sitagliptin
This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.
- Conditions
- Dyslipidaemias
- Being tested
- an undetermined dose of GSK1292263, ascending dose of GSK1292263
- Keywords
- tolerability, pharmacodynamics, pharmacokinetics, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an undetermined dose of GSK1292263Drug
GSK investigational product or placebo
ascending dose of GSK1292263Drug
Ascending dose based on target exposures or placebo
ascending dose of GSK1292263Drug
An ascending dose based on target exposure
ascending dose of GSK1292263Drug
An ascending dose based on target exposures.
ascending dose of GSK1292263Drug
An ascending dose based on target exposure
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 active 2 placebo Receives: Drug: an undetermined dose of GSK1292263 |
| Cohort 2 | Experimental | 9 active 3 placebo Receives: Drug: ascending dose of GSK1292263 |
| Cohort 3 | Experimental | Optional cohort Receives: Drug: ascending dose of GSK1292263 |
| Cohort 4 | Experimental | 12 active Receives: Drug: ascending dose of GSK1292263 |
| Cohort 5 | Experimental | 12 active Receives: Drug: ascending dose of GSK1292263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.
Measured: Up to 4 days
Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.
Measured: Up to 4 days
Secondary outcomes (3)
Pharmacodynamic endpoints
Measured: Up to four days.
• Pharmacokinetic parameters following a dose, with and without food, and bioavailability
Measured: Up to four days.
Relationships betwen drug exposures and pharmacodynamic parameters, safety, and tolerability, as appropriate.
Measured: Up to four days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start4 Sep 2008
- Primary completion31 Mar 2009
- Study completion31 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiasStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 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
- NCT00783549
- Sponsor's protocol ID
- 111596
- Status last verified
- Jul 2017
- First submitted
- 27 Oct 2008
- Last updated
- 7 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 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Volunteers of Single Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Compound Alone and When Co-administered With Sitagliptin
- ClinicalTrials.gov ID
- NCT00783549
- Acronym / sponsor ID
- 111596
- Conditions
- Dyslipidaemias
- Keywords
- tolerability, pharmacodynamics, pharmacokinetics, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2008 (actual)
- Primary completion
- 31 Mar 2009 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 31 Oct 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.
This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: an undetermined dose of GSK12922636 active 2 placebo |
| Cohort 2 | Experimental | Drug: ascending dose of GSK12922639 active 3 placebo |
| Cohort 3 | Experimental | Drug: ascending dose of GSK1292263Optional cohort |
| Cohort 4 | Experimental | Drug: ascending dose of GSK129226312 active |
| Cohort 5 | Experimental | Drug: ascending dose of GSK129226312 active |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Male or female between 18 and 55 years of age
- A female subject is eligible to participate if she is of non-childbearing potential
- Male subjects must agree to use one of the contraception methods listed in the protocol
- BMI within the range 20 - 29.9 kg/m2
- Capable of giving written informed consent, which includes compliance with protocol
Key exclusion criteria (33 listed)
- The subject has a positive pre-study drug/alcohol screen
- Positive urinary cotinine levels or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- History of regular alcohol consumption within 6 months of the study
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Unable or unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level.
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 |
|---|---|---|
| an undetermined dose of GSK1292263GSK investigational product or placebo | Drug | Cohort 1 |
| ascending dose of GSK1292263Ascending dose based on target exposures or placebo | Drug | Cohort 2 |
| ascending dose of GSK1292263An ascending dose based on target exposure | Drug | Cohort 3 |
| ascending dose of GSK1292263An ascending dose based on target exposures. | Drug | Cohort 4 |
| ascending dose of GSK1292263An ascending dose based on target exposure | Drug | Cohort 5 |
Primary outcome
Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.
Time frame: Up to 4 days
Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.
Time frame: Up to 4 days
3 secondary outcomes
Pharmacodynamic endpoints
Time frame: Up to four days.
• Pharmacokinetic parameters following a dose, with and without food, and bioavailability
Time frame: Up to four days.
Relationships betwen drug exposures and pharmacodynamic parameters, safety, and tolerability, as appropriate.
Time frame: Up to four days.
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 Jul 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 111596 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.
Related trials for Dyslipidaemias
Not yet recruiting
Improved Medication and Care to Achieve Lipid Targets After Carotid Surgery
Dyslipidaemias, Carotid Artery Stenoses
RecruitingObservational study
Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias
Patient With Dyslipidemia
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 an undetermined dose of GSK1292263 and ascending dose of GSK1292263 in people with Dyslipidaemias, run by GlaxoSmithKline at 1 site in United States.
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 6 inclusion and 33 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 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 United States. 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 parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments. (time frame: Up to 4 days). 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 Jul 2017.