DyslipidaemiasPhase 1NCT00808093
Repeat Dose Food Effect Study of GSK256073F in Healthy Adult Subjects
A Phase 1 study testing GSK256073 in people with Dyslipidaemias, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects. 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?
- GSK256073
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2008to 27 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, 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.
- Male or female of non-childbearing potential between 18 and 55 years of age.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post-last dose.
- Body weight > 50 kg (110 pounds) and BMI within the range 19 - 31 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
Who cannot join
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
- 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.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product 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 investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
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- 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. An exception is acetaminophen which is allowed at doses of ≤ 2g/day.
- 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.
- 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.
- Systolic blood pressure < 100 mmHg or ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening.
- History of significant cardiac arrhythmias
- Active peptic ulcer disease (PUD) and/or history of PUD within 1 year.
- Screening test positive for H. Pylori using the non-radioactive breath test.
- A serum uric acid concentration ≥ 8mg/dL
- History of gout and/or hyperuricemia
- History of Gilbert's syndrome
- A serum creatinine concentration above the normal reference range
- History of kidney stones
- PT and/or aPTT above the reference range
- History of recurrent indigestion, stomach upset or diarrhea
- Liver function tests (LFTs) or creatinine phosphokinase (CPK) 2X ULN
- Screening stool test positive for occult blood
- Screening peripheral blood smear with abnormal RBCs
- Reduced G6PD activity
- Serum haptoglobin outside the reference range at screening
- Total serum LDH > 1.25% above the ULN at screening
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening (between the normal reference range up to 200ng/mL).
- History of flushing (>1 episode annually)
- Fasting blood glucose ≥ 110 mg/dl and/or history of type I or type II DM
- History of intra-ocular pathology, including but not limited to retinitis, uveitis, retinal detachment and macular edema
- History of recurrent gum bleeding
- History of bleeding haemorrhoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Effect Study of GSK256073A in Healthy Subjects
The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects.
- Conditions
- Dyslipidaemias
- Being tested
- GSK256073
- Keywords
- Food Effect, GSK256073F, TRIS Salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK256073Drug
GSK256073 100 mg study drug
| Study group | Role | What they receive |
|---|---|---|
| fixed sequence | Other | fixed sequence (14 days fasted followed by 14 days either high fat or standard meal Receives: Drug: GSK256073 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions
Measured: throughout study
2. AUC0-inf, Cmax, and Ctrough (Ct) under fed conditions
Measured: throughout the study
Secondary outcomes (3)
1. Safety and tolerability will be assessed by vital signs, ECGs, clinical laboratory data, spontaneous AE reporting, nursing/physician observation and assessment of flushing via a visual analog scale
Measured: throughout the study
2. Tmax, t½ (if data permits), Ae (amount excreted in the urine), CLr (renal clearance), Cmax, ss, and Cτ following repeat dose
Measured: throughout the study
3. Pharmacodynamic endpoints may include TC, NEFA, HDL, LDL, TG, ApoA1, ApoA2, ApoB, Lp(a), CETP, adiponectin, liposcience (particle sizing) or other markers of dyslipidemia on Days 1, 14, 21, and 28, as data permit.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study start12 May 2008
- Primary completion27 Aug 2008
- Study completion27 Aug 2008
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- NCT00808093
- Sponsor's protocol ID
- 106777
- Status last verified
- Jun 2017
- First submitted
- 11 Dec 2008
- Last updated
- 5 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Effect Study of GSK256073A in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00808093
- Acronym / sponsor ID
- 106777
- Conditions
- Dyslipidaemias
- Keywords
- Food Effect, GSK256073F, TRIS Salt
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 May 2008 (actual)
- Primary completion
- 27 Aug 2008 (actual)
- Study completion
- 27 Aug 2008 (actual)
- First posted
- 15 Dec 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.
The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fixed sequence | Other | Drug: GSK256073fixed sequence (14 days fasted followed by 14 days either high fat or standard meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, 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.
- Male or female of non-childbearing potential between 18 and 55 years of age.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post-last dose.
- Body weight > 50 kg (110 pounds) and BMI within the range 19 - 31 kg/m2 (inclusive).
Key exclusion criteria (33 listed)
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
- 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.
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product 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 investigational product (whichever is longer).
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 |
|---|---|---|
| GSK256073GSK256073 100 mg study drug | Drug | fixed sequence |
Primary outcome
1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions
Time frame: throughout study
2. AUC0-inf, Cmax, and Ctrough (Ct) under fed conditions
Time frame: throughout the study
3 secondary outcomes
1. Safety and tolerability will be assessed by vital signs, ECGs, clinical laboratory data, spontaneous AE reporting, nursing/physician observation and assessment of flushing via a visual analog scale
Time frame: throughout the study
2. Tmax, t½ (if data permits), Ae (amount excreted in the urine), CLr (renal clearance), Cmax, ss, and Cτ following repeat dose
Time frame: throughout the study
3. Pharmacodynamic endpoints may include TC, NEFA, HDL, LDL, TG, ApoA1, ApoA2, ApoB, Lp(a), CETP, adiponectin, liposcience (particle sizing) or other markers of dyslipidemia on Days 1, 14, 21, and 28, as data permit.
Time frame: throughout the study
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 5 Jun 2017.
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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 GSK256073 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 7 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 5 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 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?
1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions (time frame: throughout study). 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 5 Jun 2017.