Status:
COMPLETED
Japanese phase1 Study of Belimumab (IV vs SC)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Systemic Lupus Erythematosus
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and s...
Eligibility Criteria
Inclusion
- Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. Rationale: Set for the appropriate selection of healthy males
- Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- Body weight greater than and equal to 50.0 kg and BMI within the range 18.5 more than and equal to - less than 25.0 kg/m2. Rationale: To include those who have a standard figure based on the obesity criteria of the Obesity Association in Japan, these ranges are established
- Non-smoker or ex-smoker having ceased smoking for at least 6 months. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- AST, ALT, alkaline phosphatase and total bilirubin less than and equal to ULN at screening. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Rationale: Set in consideration of ethics of the study in accordance with GCP.
- Single QTc \[QTcF\] less than 450 msec. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
Exclusion
- A positive test for syphilis, Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B core antibody, or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 antibody at screening. Rationale: Set for the appropriate selection of healthy subjects and in consideration of safety of the staff that handle or measure the blood samples.
- A positive pre-study drug screen at screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the administration of study medication of this study. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Exposure to more than four new chemical entities within 12 months prior to the dosing day. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- The subject planned to concurrently participate in another clinical study or post-marketing study. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the administration of study medication. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy excluding pollen allergy without current symptoms. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Where participation in the study would result in donation of blood or blood products in excess of 400 mL within 4 month or 200 mL within 2 months.
- Unwillingness or inability to follow the procedures outlined in the protocol. Rationale: Set to secure study quality
- Subject is mentally or legally incapacitated. Rationale: Set to secure study quality
- Subjects with ECG results considered clinically significant by the investigator. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Subjects with a supine systolic blood pressure less than 90 mmHg or greater than140 mmHg and/or a supine diastolic blood pressure less than 55 mmHg or greater than 90 mmHg and/or systolic blood pressure drop from supine to standing of greater than 30 mmHg. Rationale: Set in consideration of subjects' safety related to the IV route of administration.
- Immunoglobulin (M, A, G) level is less than LLN at screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of anaphylactic reaction to any food, drug, or insect bite/sting. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of allergic reaction to parenteral administration of contrast agents, foreign proteins, or monoclonal antibodies. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of B cell targeted therapy (rituximab, other anti-CD20agents, anti-CD22 \[epratuzumab\], anti-CD52 \[alemtuzumab\], BLyS-receptor fusion protein \[BR3\], TACI-Fc, LY2127399 \[anti-BAFF\] or GSK1550188) at any time. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of any infection requiring hospitalization or treatment with antivirals or antibiotics, or vaccination within 30 days prior to administration of study medication. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
Key Trial Info
Start Date :
December 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01516450
Start Date
December 26 2011
End Date
April 11 2012
Last Update
June 12 2017
Active Locations (1)
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1
GSK Investigational Site
Tokyo, Japan, 130-0004