Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag

NCT00688272 | Completed Phase 1

• 1 other identifier: TRA106914
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Safety; Photoirritant; Photosensitivity; Placebo control; Ciprofloxacin; Eltrombopag

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening - Day 8

Secondary Outcomes (4)

• Severity of phototoxic response Concentration of porphyrins, ANF, anti-Ro, and anti-La as measured on Day 6.

  Day 6

• Vital signs (blood pressure, heart rate, respiration rate and body temperature) taken after resting semi-supine position for at least 10 minutes;

  Screening, Days 1,2,3,4,5,6,7, and f/u

• Clinical laboratory tests

  Screening, Day 1, 7 and f/u

• Assessment of AEs.

  Continuous trhoughout the study.

Study Arms (3)

Arm 1

EXPERIMENTAL

Eltrombopag 75 mg QD x 6 days

Drug: Eltrombopag

Arm 2

ACTIVE COMPARATOR

Ciprofloxicin 500mg BID x 6 days

Drug: Ciprofloxacin

Arm 3

PLACEBO COMPARATOR

Placebo QD x 6 days

Drug: Placebo

Interventions

Ciprofloxacin DRUG

Given 500mg BID x 6 days

Arm 2

Eltrombopag DRUG

Given QD x 6 days

Also known as: Ciprofloxacin

Arm 1

Placebo DRUG

Given QD x 6 days

Arm 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20831698 BACKGROUND

Related Links

• Results for study TRA106914 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Purpura; Photosensitivity Disorders

Interventions

Ciprofloxacin; eltrombopag

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: June 2, 2008
• Primary Completion: September 25, 2008
• Study Completion: September 25, 2008
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

GB (1)