Purpura, Thrombocytopaenic, IdiopathicPhase 1NCT00688272
Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag
A Phase 1 study testing Ciprofloxacin and Eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study is designed to investigate the safety profile and the photoirritant potential of eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized, parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive control (ciprofloxacin, 500 mg BID). 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?
- Ciprofloxacin and Eltrombopag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2008to 25 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Caucasian male or females with no clinically significant abnormality identified by the physician by evaluation of medical history, physical examination, clinical laboratory tests or 12-lead ECG.
- Subjects were adult males or females between 18 and 65 years of age, inclusive.
- All female subjects of child bearing potential agreed to commit to one of the protocol approved methods of contraception, and that they were used consistently and in accordance with both the product label and the instructions of a physician. Female participants are not permitted to use Hormonal form of contraception (combined oral contraceptive pills etc) because of its known potential to induce photosensitivity.
- All male subjects agreed to abstain completely from (or use a condom during) sexual intercourse with a pregnant or lactating female.
- All male subjects with partner(s) who is /are able to have children agreed to use condom with spermicide from screening until 90 days after the last dose of study medication. In addition, their partner (s) had to also use one of the following forms of contraception until 90 days after last date of study medication:
- Hormonal contraception i.e. the pill or hormones given by injection or given under the skin.
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- Diaphragm with spermicide
- Cervical cap or female condoms.
- An intrauterine device (a coil micro-insert).
- Intrauterine system (IUS) e-g Mirena coil
- Tubal ligation
- Body weight greater than or equal to 50 kg and body mass index within the range 19-29.9 kg/m2.
- A signed and dated written informed consent was obtained for the subject.
- Skin Type 1, 2, or 3 according to the dermatological scale presented in the study protocol (see Modular Appendices).
- Negative test for porphyrins, ANF, anti-Ro and anti-La (tests for lupus erythematosus) at screening.
- Liver function tests (LFTs; AST, ALT, ALP, bilirubin, gamma-GT) within the reference range, or deviations that were not considered clinically significant at screening by the investigator.
- Subjects who had a normal value of MED in comparison with the normal population databank at the photobiology unit, Dundee.
- The subject was able to understand and comply with protocol requirements and time tables, instructions and protocol-stated restrictions Exclusion Criteria
- Any abnormality identified on the screening medical assessment that in the opinion of the investigator and GlaxoSmithKline medical monitor could have been associated with an increased rish to the subject or could have interfered with study procedures.
- Subjects who had any sun or sunbed exposure to the skin of the back during the four weeks prior to the screening period.
- Subjects with history of polymorphic light eruption.
- Subjects who had a history of sensitivity to ciprofloxacin, any of the study medications or components thereof.
- Subjects with history of malignant melanoma in a first degree family member.
- Subjects with history of Gilbert Syndrome.
- Subjects with history of deep vein thrombosis or any other thromboembolic event.
- Subjects with history of sensitivity to heparin, or heparin-induced thrombocytopenia.
- Subjects with history of platelet clumping that prevents reliable measurement of platelet counts.
- Subjects with history of thrombocytopenia or bleeding due to abnormal platelet number or function.
- Subjects with C-reactive protein (CRP) that is elevated above normal range and considered clinically significant at screening.
- Subjects with history of myocardial infarction, stroke or sudden unexplained death in a first degree family member under the age of 60 years.
- Subjects with clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C, or Protein S deficiency, or antithrombin III deficiency.
- Subjects with haemoglobin, white blood cells, platelet count or reticulocyte count that are outside the reference range and considered clinically significant at screening by the investigator.
- Subjects with positive test for HIV, hepatitis B virus or hepatitis C virus.
- Subjects with positive urine drug screen including alcohol.
- Subjects with history of alcohol/drug abuse or dependence within 12 months of screening.
- History of regular alcohol consumption exceeding average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint (220 mL) of beer/lager or one (25 mL) measure of spirits or one glass (125 mL) of wine.
- Subjects who could not refrain from smoking during the study period from Day-1 through the completion of follow-up assessments.
- Subjects who had received treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
- Subjects who had been exposed to more than four new chemical entities within 12 months prior to the first dosing day.
- Subjects who had taken any prescription or non-prescription drugs (including aspirin and NSAIDs), vitamins, herbal and dietary supplements, or any herbal remedies containing St. John's Wort within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication and through the completion of follow-up assessments. By exception, acetaminophen (or, paracetamol) at doses of less than or equal to 2 g/day and stable thyroid replacement therapy was allowed.
- Consumption of antacids (e.g., Maalox, Mylanta, Amphogel, Milk of Magnesia or TUMS™) within 48 h of the first dose of study medication and until the completion of follow-up assessments.
- Subjects who had an clinically significant skin/allergic disease, including photo-allergy (excluding non
- active hay fever).
- Subjects with multiple tattoos which may have obscured skin reactions or which restricted the skin surface area available for testing.
- Subjects had to abstain from consumption of grapefruit, pomelo or Seville oranges from screening until the completion of follow-up assessments
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-blind, Placebo and Observer-blind Positive Controlled, Randomized, Parallel Group Study in Healthy Subjects to Investigate the Photoirritant Potential of Eltrombopag
This study is designed to investigate the safety profile and the photoirritant potential of eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized, parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind fashion with respect to placebo and the positive control, ciprofloxacin, will be administered under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change in minimum erythemal dose (MED) in comparison with placebo.
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Being tested
- Ciprofloxacin, Eltrombopag, Placebo
- Keywords
- Safety, Photoirritant, Photosensitivity, Placebo control, Ciprofloxacin, Eltrombopag
- Medical subject headings
- Purpura, Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Given 500mg BID x 6 days
EltrombopagDrug
Also called Ciprofloxacin
Given QD x 6 days
PlaceboDrug
Given QD x 6 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Eltrombopag 75 mg QD x 6 days Receives: Drug: Eltrombopag |
| Arm 2 | Active comparator | Ciprofloxicin 500mg BID x 6 days Receives: Drug: Ciprofloxacin |
| Arm 3 | Placebo comparator | Placebo QD x 6 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the photosensitizing potential, as measured by photoirritant index and change from baseline in minimum erythemal dose, of eltrombopag when dosed orally at 75 mg QD as compared to placebo and ciprofloxacin 500 mg BID.
Measured: Screening - Day 8
Secondary outcomes (4)
Severity of phototoxic response Concentration of porphyrins, ANF, anti-Ro, and anti-La as measured on Day 6.
Measured: Day 6
Vital signs (blood pressure, heart rate, respiration rate and body temperature) taken after resting semi-supine position for at least 10 minutes;
Measured: Screening, Days 1,2,3,4,5,6,7, and f/u
Clinical laboratory tests
Measured: Screening, Day 1, 7 and f/u
Assessment of AEs.
Measured: Continuous trhoughout 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 Jun 2008 (estimated)
- Study start2 Jun 2008
- Primary completion25 Sep 2008
- Study completion25 Sep 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT00688272
- Sponsor's protocol ID
- TRA106914
- Status last verified
- Nov 2017
- First submitted
- 28 May 2008
- Last updated
- 17 Nov 2017
- Results posted
- No
Publications
Bowen CJ, Lobb KM, Park JW, Sanderson B, Ferguson J. Eltrombopag (75 mg) does not induce photosensitivity: results of a clinical pharmacology trial. Photodermatol Photoimmunol Photomed. 2010 Oct;26(5):243-9. doi: 10.1111/j.1600-0781.2010.00538.x.
PubMed 20831698
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Placebo and Observer-blind Positive Controlled, Randomized, Parallel Group Study in Healthy Subjects to Investigate the Photoirritant Potential of Eltrombopag
- ClinicalTrials.gov ID
- NCT00688272
- Acronym / sponsor ID
- TRA106914
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Keywords
- Safety, Photoirritant, Photosensitivity, Placebo control, Ciprofloxacin, Eltrombopag
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2008 (actual)
- Primary completion
- 25 Sep 2008 (actual)
- Study completion
- 25 Sep 2008 (actual)
- First posted
- 2 Jun 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 designed to investigate the safety profile and the photoirritant potential of eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized, parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind fashion with respect to placebo and the positive control, ciprofloxacin, will be administered under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change in minimum erythemal dose (MED) in comparison with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EltrombopagEltrombopag 75 mg QD x 6 days |
| Arm 2 | Active comparator | Drug: CiprofloxacinCiprofloxicin 500mg BID x 6 days |
| Arm 3 | Placebo comparator | Drug: PlaceboPlacebo QD x 6 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Healthy Caucasian male or females with no clinically significant abnormality identified by the physician by evaluation of medical history, physical examination, clinical laboratory tests or 12-lead ECG.
- Subjects were adult males or females between 18 and 65 years of age, inclusive.
- All female subjects of child bearing potential agreed to commit to one of the protocol approved methods of contraception, and that they were used consistently and in accordance with both the product label and the instructions of a physician. Female participants are not permitted to use Hormonal form of contraception (combined oral contraceptive pills etc) because of its known potential to induce photosensitivity.
- All male subjects agreed to abstain completely from (or use a condom during) sexual intercourse with a pregnant or lactating female.
- All male subjects with partner(s) who is /are able to have children agreed to use condom with spermicide from screening until 90 days after the last dose of study medication. In addition, their partner (s) had to also use one of the following forms of contraception until 90 days after last date of study medication:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CiprofloxacinGiven 500mg BID x 6 days | Drug | Arm 2 |
| EltrombopagAlso: CiprofloxacinGiven QD x 6 days | Drug | Arm 1 |
| PlaceboGiven QD x 6 days | Drug | Arm 3 |
Primary outcome
Evaluate the photosensitizing potential, as measured by photoirritant index and change from baseline in minimum erythemal dose, of eltrombopag when dosed orally at 75 mg QD as compared to placebo and ciprofloxacin 500 mg BID.
Time frame: Screening - Day 8
4 secondary outcomes
Severity of phototoxic response Concentration of porphyrins, ANF, anti-Ro, and anti-La as measured on Day 6.
Time frame: Day 6
Vital signs (blood pressure, heart rate, respiration rate and body temperature) taken after resting semi-supine position for at least 10 minutes;
Time frame: Screening, Days 1,2,3,4,5,6,7, and f/u
Clinical laboratory tests
Time frame: Screening, Day 1, 7 and f/u
Assessment of AEs.
Time frame: Continuous trhoughout 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 17 Nov 2017.
- Background: PubMed 20831698Bowen CJ, Lobb KM, Park JW, Sanderson B, Ferguson J. Eltrombopag (75 mg) does not induce photosensitivity: results of a clinical pharmacology trial. Photodermatol Photoimmunol Photomed. 2010 Oct;26(5):243-9. doi: 10.1111/j.1600-0781.2010.00538.x.
- Results for study TRA106914 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
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 Ciprofloxacin and Eltrombopag in people with Purpura, Thrombocytopaenic, Idiopathic, run by GlaxoSmithKline at 1 site in United Kingdom.
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 45 inclusion and 0 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 17 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 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Evaluate the photosensitizing potential, as measured by photoirritant index and change from baseline in minimum erythemal dose, of eltrombopag when dosed orally at 75 mg QD as compared to placebo and ciprofloxacin 500 mg BID. (time frame: Screening - Day 8). 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 NCT00688272, 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 17 Nov 2017.