Purpura, Thrombocytopaenic, IdiopathicPhase 1NCT00359463
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
A Phase 1 study testing eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 5 sites in 3 countries.
Trial summary
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Purpura, Thrombocytopaenic, Idiopathic
- What is being tested?
- eltrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 18 Apr 2006to 7 Mar 2007
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy or have liver impairment
- Females(the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy.
- Body mass index (BMI-within acceptable range)
- Negative drug, alcohol, and HIV tests
Who cannot join
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing liver function
- Kidneys not working well
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
- Females that are pregnant or nursing
Show all 10Show fewer
- Have active hepatitis B or C
- History of blood disorders
- History of various heart conditions (as noted by study doctor)
- Blood clotting problems or blood abnormalities
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Orlando, Florida, 32809
Australia2 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Randwick, Sydney, New South Wales, 2031
About this study
Official title: An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers With Mild, Moderate or Severe Hepatic Impairment
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Being tested
- eltrombopag
- Keywords
- hepatitis C-associated thrombocytopenia, chemotherapy induced thrombocytopenia, thrombocytopenia, hepatic impairment, chronic immune thrombocytopenia purpura
- Medical subject headings
- Purpura, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopagDrug
Subjects will be administered a single oral dose of 50 mg eltrombopag.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Active comparator | Subjects will receive a single 50 mg oral dose of eltrombopag. Receives: Drug: eltrombopag |
| Subjects with hepatic impairment | Experimental | Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag. Receives: Drug: eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels and protein binding of eltrombopag
Measured: Day 1 to Day 6
Secondary outcomes (1)
Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
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 posted2 Aug 2006 (estimated)
- Study start18 Apr 2006
- Primary completion7 Mar 2007
- Study completion7 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Purpura, Thrombocytopaenic, IdiopathicStudies 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
- 33 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
- NCT00359463
- Sponsor's protocol ID
- TRA103452
- Status last verified
- Nov 2017
- First submitted
- 28 Jul 2006
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauman JW, Vincent CT, Peng B, Wire MB, Williams DD, Park JW. Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. J Clin Pharmacol. 2011 May;51(5):739-50. doi: 10.1177/0091270010372106. Epub 2010 Jul 27.
PubMed 20663991
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers With Mild, Moderate or Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT00359463
- Acronym / sponsor ID
- TRA103452
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Keywords
- hepatitis C-associated thrombocytopenia, chemotherapy induced thrombocytopenia, thrombocytopenia, hepatic impairment, chronic immune thrombocytopenia purpura
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2006 (actual)
- Primary completion
- 7 Mar 2007 (actual)
- Study completion
- 7 Mar 2007 (actual)
- First posted
- 2 Aug 2006 (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 main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Active comparator | Drug: eltrombopagSubjects will receive a single 50 mg oral dose of eltrombopag. |
| Subjects with hepatic impairment | Experimental | Drug: eltrombopagSubjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy or have liver impairment
- Females(the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy.
- Body mass index (BMI-within acceptable range)
- Negative drug, alcohol, and HIV tests
Key exclusion criteria (10 listed)
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing liver function
- Kidneys not working well
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
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 |
|---|---|---|
| eltrombopagSubjects will be administered a single oral dose of 50 mg eltrombopag. | Drug | Healthy subjects, Subjects with hepatic impairment |
Primary outcome
Plasma levels and protein binding of eltrombopag
Time frame: Day 1 to Day 6
1 secondary outcome
Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
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 13 Nov 2017.
- Background: PubMed 20663991Bauman JW, Vincent CT, Peng B, Wire MB, Williams DD, Park JW. Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. J Clin Pharmacol. 2011 May;51(5):739-50. doi: 10.1177/0091270010372106. Epub 2010 Jul 27.
- Results for study 103452 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 5 sites in 3 countries.
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 4 inclusion and 10 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, New Zealand. 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?
Plasma levels and protein binding of eltrombopag (time frame: Day 1 to Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359463, which also lists 1 linked publication.
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 13 Nov 2017.