Healthy Clinical Trial
Official title:
A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884
The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.
This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study
Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese
subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel
studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in
a single and multiple dose open-label study.
Two dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up
to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2
cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in
a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.
Following a screening period of a maximum of 42 days, subjects will reside at the study
facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of
discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose
administration in all 3 study arms will be done in the following sequence: a single dose of
D5884 or placebo will be administered; this will be followed by a 2-day washout period;
after the washout period, multiple doses of D5884 or placebo will be administered, once
daily for 14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or
placebo (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3)
and the 3rd cohort (Study Arm C) will receive 4 g D5884 (n=6).
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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