Status:
COMPLETED
Phase1 Study of GR121167, Single and Multiple Dose Study in Healthy Japanese Males
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza, Human
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete crossover, single and multiple dose study in healthy Japanese male subjects to assess the pharmacokinetics and ...
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.
- Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
- Body weight \>= 50.0 kg and BMI within the range 18.5\<= - \<25.0 kg/m2 (inclusive).
- A creatinine clearance \>= 80ml/min as determined by Cockcroft-Gault equation:CLcr (mL/min) = (140 - age) \* Wt / (72 \* Scr). Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dl. \[Cockcroft, 1976\]
- Non-smoker or ex-smoker having ceased smoking for at least 6 months.
- AST, ALT, alkaline phosphatase and total bilirubin =\< ULN at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion
- A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 at screening
- A positive pre-study drug screen at screening.
- 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.
- 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 first dose of study medication of this study
- The subject planned to concurrently participate in another clinical study or post-marketing study.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- 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.
- 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.
- Consumption of red wine, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
- Single QTcB \>= 450 msec; at screening
- Subjects with ECG results considered clinically significant by the investigator.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes or additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia).
- Subjects with a family history of sudden cardiac death.
- Subjects with a supine systolic blood pressure \<90mmHg or \>140mmHg and/or a supine diastolic blood pressure \<55mmHg or \>90mmHg and/or systolic blood pressure drop from supine to standing of \>30mmHg.
- History of renal failure or renal dysfunction
Key Trial Info
Start Date :
January 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01428479
Start Date
January 7 2011
End Date
April 4 2011
Last Update
July 21 2017
Active Locations (1)
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1
GSK Investigational Site
Tokyo, Japan, 160-0017