Healthy SubjectsPhase 1NCT00539136
A Study to Examine the Absorption of GSK561679 in Healthy Male Volunteers
A Phase 1 study testing GSK561679 tablet or solution in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will be conducted in healthy volunteers to investigate the absorption of GSK561679 using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- GSK561679 tablet or solution
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged 18-55 years, inclusive.
- Healthy subjects, defined as individuals who are free from clinically significant illness or disease (including peptic ulcer disease and psychiatric illness) as determined by their medical and psychiatric history (including family), physical examination, laboratory studies, and other tests.
- Body weight >/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive
- Demonstrates no evidence of active disease, physical or mental impairment.
- Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
- Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
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- Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG).
- Agree to remain in the clinic for the time defined in the protocol.
- Signed and dated written informed consent prior to admission to the study.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations, the physician responsible considers the subject unfit for the study.
- History of clinically significant psychiatric illness.
- Any history of suicidal attempts or behavior.
- Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome or intestinal obstruction; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
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- History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- LFTs elevated >1.5 times above the reference range at pre-study screening that remain elevated with a repeat LFT (to be discussed with the sponsor, if necessary).
- Any other clinically significant laboratory abnormality.
- The subject has a screening ECG with values outside ranges specified in protocol.
- A semi-supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg or a semi-supine diastolic blood pressure of less than 60 mmHg or greater than 90mmHg; or a radial pulse rate less than 40 bpm or more than 90 bpm.
- A positive pre-study HIV 1, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study. Subjects with a negative Hepatitis B, C and HIV test in last 3 months will not be required to repeat the tests.
- The subject has a positive pre-study urine drug/alcohol screen. .
- History of regular alcohol consumption averaging 21 drinks/week within 6 months of screening.
- Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
- Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
- The subject is a vegetarian and/or has specific dietary requirements which would prevent them from eating the meals provided during the study.
- 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 sponsor the medication will not interfere with the study procedures or compromise subject safety.
- An unwillingness to use a condom/spermicide during sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until five half lives following administration of the last dose of study medication.
- An unwillingness to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 84 days following administration of the last dose of study medication.
- The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
- Where participation in the study would result in donation of excess of 600 mL blood within a 56 day period.
- Radiation exposure, including that from the present study, exceeding a cumulative total effective dose equivalent of 10mSv over the last 3 years. Radiation exposure from previous clinical trials will be included, but clinical (therapeutic or diagnostic) radiation exposures will not be included.
- Radiation exposure from clinical trials, including that from present study, and from diagnostic X-rays, but excluding background radiation, exceeding a target organ (colon) dose of 50mSv (5 rems) from a single dose within the last 30 days or a cumulative dose of 150mSv (15 rems) in the last twelve (12) months. No subject whose occupation requires monitoring for radiation exposure will be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose, Non-randomized, Balanced Design Three-way Cross-over Study to Examine the Variability in Absorption of GSK561679 Using Gamma Scintigraphy, PillCam™ SB Capsule and the Acoustic Vest in Healthy Males Volunteers
This study will be conducted in healthy volunteers to investigate the absorption of GSK561679 using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest.
- Conditions
- Healthy Subjects
- Being tested
- GSK561679 tablet or solution
- Keywords
- GSK561679,, Pharmacokinetic,, healthy volunteers,, Gamma Scintigraphy,, PillCam™,, acoustic vest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK561679 tablet or solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic scope of GSK561679 after application in a solution and in a new tablet formula per treatment phase Complete gastric emptying of radioactive marker after application of GSK561679 Complete tablet breakdown per treatment phase
Secondary outcomes (3)
AUC(0-24h), AUC(0-t), AUC(0-∞) of GSK561679 after administration of GSK561679 in a solution (fasted) and in a new "optimized" tablet formulation (fasted and fed).
lambda_Z (and t1/2), tlag, Ka, the time to absorb the 25, 50 and 90% of the total absorbed dose
•Other pharmacokinetic parameters of GSK561679 per treatment phase •Safety and tolerability parameters, including adverse events, clinical laboratory,vital signs and 12-lead ECGs measured at each dosing period and 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 posted4 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539136
- Sponsor's protocol ID
- CRS-110300
- Status last verified
- Oct 2010
- First submitted
- 3 Oct 2007
- Last updated
- 19 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Non-randomized, Balanced Design Three-way Cross-over Study to Examine the Variability in Absorption of GSK561679 Using Gamma Scintigraphy, PillCam™ SB Capsule and the Acoustic Vest in Healthy Males Volunteers
- ClinicalTrials.gov ID
- NCT00539136
- Acronym / sponsor ID
- CRS-110300
- Conditions
- Healthy Subjects
- Keywords
- GSK561679,, Pharmacokinetic,, healthy volunteers,, Gamma Scintigraphy,, PillCam™,, acoustic vest
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 Oct 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.
This study will be conducted in healthy volunteers to investigate the absorption of GSK561679 using Gamma Scintigraphy, PillCam™ SB capsule and the acoustic vest.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy males aged 18-55 years, inclusive.
- Healthy subjects, defined as individuals who are free from clinically significant illness or disease (including peptic ulcer disease and psychiatric illness) as determined by their medical and psychiatric history (including family), physical examination, laboratory studies, and other tests.
- Body weight >/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive
- Demonstrates no evidence of active disease, physical or mental impairment.
- Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
Key exclusion criteria (24 listed)
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations, the physician responsible considers the subject unfit for the study.
- History of clinically significant psychiatric illness.
- Any history of suicidal attempts or behavior.
- Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
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 |
|---|---|---|
| GSK561679 tablet or solution | Drug | – |
Primary outcome
Pharmacokinetic scope of GSK561679 after application in a solution and in a new tablet formula per treatment phase Complete gastric emptying of radioactive marker after application of GSK561679 Complete tablet breakdown per treatment phase
3 secondary outcomes
AUC(0-24h), AUC(0-t), AUC(0-∞) of GSK561679 after administration of GSK561679 in a solution (fasted) and in a new "optimized" tablet formulation (fasted and fed).
lambda_Z (and t1/2), tlag, Ka, the time to absorb the 25, 50 and 90% of the total absorbed dose
•Other pharmacokinetic parameters of GSK561679 per treatment phase •Safety and tolerability parameters, including adverse events, clinical laboratory,vital signs and 12-lead ECGs measured at each dosing period and 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 19 Oct 2010.
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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, MD 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 GSK561679 tablet or solution in people with Healthy Subjects, 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 10 inclusion and 24 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 19 Oct 2010. 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?
Pharmacokinetic scope of GSK561679 after application in a solution and in a new tablet formula per treatment phase Complete gastric emptying of radioactive marker after application of GSK561679 Complete tablet breakdown per treatment phase. 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 19 Oct 2010.