Phase1 Study of GR121167, Single and Multiple Dose Study in Healthy Japanese Males
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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-|
- Profile of pharmacokinetics [ Time Frame: 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 ] [ Designated as safety issue: No ]Cmax, AUC0-inf, AUC0-last, AUC0-12, C12 (Cτ), accumulation ratios (Ro, Rs)
- Safety parameters [ Time Frame: upto 24 hrs after dose and 7 days after final dose ] [ Designated as safety issue: Yes ]vital signs, ECGs, clinical laboratory tests, and adverse events
- Profile of urinary pharmacokinetics [ Time Frame: 0-4, 4-8, 8-12, 12-24hrs after single dose ] [ Designated as safety issue: No ]Ae, fe, CLr
- Profile of serum pharmacokinetics [ Time Frame: Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose ] [ Designated as safety issue: No ]AUC0-24, %AUCex, λz, tmax, t1/2, CL, Vz, Vss
|Study Start Date:||January 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|