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Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag
This study is currently recruiting participants.
Verified by GlaxoSmithKline, October 2008
First Received: May 28, 2008   Last Updated: October 15, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00688272
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Ciprofloxacin
Drug: Eltrombopag
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Single Group Assignment, Safety 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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;
  • Clinical laboratory tests
  • Assessment of AEs.

Estimated Enrollment: 36
Study Start Date: June 2008
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • Age 18 to 65 years, inclusive.
  • Female who is neither pregnant nor lactating, and is of non-childbearing potential or child-bearing potential with negative βhCG test and agrees to comply with recognized non-hormonal contraceptive methods
  • Body weight >/50 kg and BMI within the range 19-29.9 kg/m2.
  • Capable of giving written informed consent.
  • Skin Type 1, 2, or 3 according to protocol criteria
  • Negative test for porphyrins, ANF, anti-Ro and anti-La at screening.
  • Liver function tests that are within the reference range, or deviations that are not considered clinically significant at screening by the investigator.
  • Baseline MED within the normal range
  • Able to understand and comply with protocol requirements and time tables, instructions and protocol-stated restrictions.

Exclusion Criteria:

  • Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or 12-lead ECG.
  • Any sun or sunbed exposure to the skin of the back during the four weeks prior to the screening period.
  • History of polymorphic light eruption.
  • History of previously severe photosensitivity to ciprofloxacin, any of the study medications or components thereof.
  • History of malignant melanoma in a first degree family member.
  • History of Gilbert Syndrome.
  • History of deep vein thrombosis or any other thromboembolic event.
  • History of sensitivity to heparin, or heparin-induced thrombocytopenia.
  • History of platelet clumping that prevents reliable measurement of platelet counts.
  • History of thrombocytopenia or bleeding due to abnormal platelet number or function.
  • C-reactive protein (CRP) that is elevated above normal range and considered clinically significant at screening.
  • History of myocardial infarction, stroke or sudden unexplained death in a first degree family member under the age of 60 years.
  • Clotting factor abnormalities associated with hypercoagulability.
  • Hemoglobin, white blood cells, platelet count or reticulocyte count that are outside the reference range and considered clinically significant at screening by the investigator.
  • Positive test for HIV, hepatitis B virus or hepatitis C virus.
  • Positive urine drug screen including alcohol.
  • 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). .
  • Cannot refrain from smoking during the study period from Day-1 through the completion of follow-up assessments.
  • Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of 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 </2 g/day and stable thyroid replacement therapy will be allowed.
  • Consumption of antacids (e.g., Maalox, Mylanta, Amphogel, Milk of Magnesia or TUMS™) within 48 hrs of the first dose of study medication and until the completion of follow-up assessments.
  • Clinically significant skin/allergic disease, including photo-allergy (excluding non-active hay fever).
  • Tattoos that may obscure skin reactions or that restrict the skin surface area available for testing.
  • Consumption of grapefruit, pomelo or Seville oranges from screening until the completion of follow-up assessments.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688272

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
United Kingdom, Forfarshire
GSK Investigational Site Recruiting
Dundee, Forfarshire, United Kingdom, DD1 9SY
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: TRA106914
Study First Received: May 28, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00688272     History of Changes
Health Authority: United States: Food and Drug Administration;   European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Safety
Photoirritant
Photosensitivity
Placebo control
Ciprofloxacin
Eltrombopag

Additional relevant MeSH terms:
Anti-Infective Agents
Ciprofloxacin
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010