Purpura, Thrombocytopaenic, IdiopathicPhase 1NCT00442871
Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment
A Phase 1 study testing eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2006to 3 Jan 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy or have renal 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
- Negative drug, alcohol, and HIV tests.
Who cannot join
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing kidney function
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
- Females who are pregnant or nursing
- Have active hepatitis B or C
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Saint Paul, Minnesota, 55114-1067
About this study
Official title: An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50 mg Eltrombopag in Healthy Subjects and in Subjects With Mild, Moderate, or Severe Renal Impairment
The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney 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
- Renal Impairment,, chronic immune thrombocytopenia purpura,, thrombocytopenia,, chemotherapy induced thrombocytopenia
- Medical subject headings
- Purpura, Renal Insufficiency, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopagDrug
eltrombopag 50 mg oral
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | Eltrombopag 50 mg oral (single dose) 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
plasma levels/protein binding for eltrombopag
Measured: at Day 1 to Day 6.
Secondary outcomes (3)
Safety will be assessed by: -eye exam
eye exam safety findings
Measured: at Screening, Day -1, & followup
adverse assessment
Adverse event review
Measured: Day 1 to followup
clinical labs, vital signs, & 12-lead electrocardiograms done
Clinical labs, vital signs and 12 lead electrocardiograms
Measured: all days but Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study start28 Sep 2006
- Primary completion3 Jan 2008
- Study completion3 Jan 2008
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
- Single group
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT00442871
- Sponsor's protocol ID
- TRA104412
- Status last verified
- Nov 2017
- First submitted
- 1 Mar 2007
- 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 50 mg Eltrombopag in Healthy Subjects and in Subjects With Mild, Moderate, or Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT00442871
- Acronym / sponsor ID
- TRA104412
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Keywords
- Renal Impairment,, chronic immune thrombocytopenia purpura,, thrombocytopenia,, chemotherapy induced thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2006 (actual)
- Primary completion
- 3 Jan 2008 (actual)
- Study completion
- 3 Jan 2008 (actual)
- First posted
- 5 Mar 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.
The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney 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
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag | Experimental | Drug: eltrombopagEltrombopag 50 mg oral (single dose) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy or have renal 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
- Negative drug, alcohol, and HIV tests.
Key exclusion criteria (6 listed)
- Taking a medication or therapy not approved by the study doctor
- Rapidly changing kidney function
- Drug or alcohol abuse within past 6 months
- Used an investigational drug in the past 30 days
- Females who are pregnant or nursing
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 |
|---|---|---|
| eltrombopageltrombopag 50 mg oral | Drug | Eltrombopag |
Primary outcome
Plasma levels and protein binding of eltrombopag
Time frame: at Day 1 to Day 6.
plasma levels/protein binding for eltrombopag
3 secondary outcomes
Safety will be assessed by: -eye exam
Time frame: at Screening, Day -1, & followup
adverse assessment
Time frame: Day 1 to followup
clinical labs, vital signs, & 12-lead electrocardiograms done
Time frame: all days but Day 4
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 TRA104412 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
2 sites in 1 country: 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 2 sites 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 3 inclusion and 6 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 2 sites 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?
Plasma levels and protein binding of eltrombopag (time frame: at 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 NCT00442871, 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.