Last updated: 11/07/2018 08:34:44
Phase1 study of GR121167, single and multiple dose study in healthy Japanese males
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase1 study of GR121167- A double blind, placebo controlled, randomized, dose ascending, single and multiple dose study to investigate the safety and pharmacokinetics following intravenous administration of GR121167 in healthy Japanese males-
Trial description: 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 safety/tolerability of single and multiple intravenous administration of GR121167. Serial blood samples and pooled urine samples for the determination of GR121167 concentration will be collected and safety assessments will be performed for each treatment period. The pharmacokinetics and dose proportionality of GR121167 after single intravenous administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed. In addition, in the final treatment period (600 mg), twice daily intravenous administrations for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Profile of pharmacokinetics
Timeframe: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose, and at the trough during multiple doses
Safety parameters
Timeframe: upto 24 hrs after dose and 7 days after final dose
Secondary outcomes:
Profile of urinary pharmacokinetics
Timeframe: 0-4, 4-8, 8-12, 12-24hrs after single dose
Profile of serum pharmacokinetics
Timeframe: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose
Interventions:
Drug: GR121167 Solution
Drug: Placebo
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Yuri Shida, Katsutoshi Hara, Shigeru Nohda, Toru Soutome, Toshiyasu Hirama. The pharmacokinetic and safety profiles of zanamivir after single and repeat intravenous administration in healthy Japanese males. J Clin Pharm Ther. 2013;38:236-240
Medical condition
Influenza, Human
Product
zanamivir
Collaborators
Not applicable
Study date(s)
January 2011 to April 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
20 - 55 years
Accepts healthy volunteers
Yes
- 1. 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.
- 2. Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
- 1. A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 at screening
- 2. A positive pre-study drug screen at screening.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. 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. 2. Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent. 3. Body weight >= 50.0 kg and BMI within the range 18.5<= – <25.0 kg/m2 (inclusive). 4. 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] 5. Non-smoker or ex-smoker having ceased smoking for at least 6 months. 6. AST, ALT, alkaline phosphatase and total bilirubin =< ULN at screening. 7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria:
- 1. A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 at screening 2. A positive pre-study drug screen at screening. 3. 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. 4. 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 5. The subject planned to concurrently participate in another clinical study or post-marketing study. 6. 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. 7. 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. 8. 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. 9. Unwillingness or inability to follow the procedures outlined in the protocol. 10. Consumption of red wine, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication. 11. Single QTcB >= 450 msec; at screening 12. Subjects with ECG results considered clinically significant by the investigator. 13. 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). 14. Subjects with a family history of sudden cardiac death. 15. 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. 16. History of renal failure or renal dysfunction
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-04-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 115070 can be found on the GSK Clinical Study Register.
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