A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
oral capsule/tablet, QD
oral capsule/tablet, QD
oral capsule/tablet, QD
Theravance Biopharma Investigational Site
Cypress, California, United States
Area under the concentration-time curve (AUC0 t)
Time frame: Day 1 & Day 14
Area under the concentration-time curve (AUC0 24)
Time frame: Day 1 & Day 14
Area under the concentration-time curve (AUCtau)
Time frame: Day 1 & Day 14
Maximum observed concentration (Cmax)
Time frame: Day 1 & Day 14
Maximum observed concentration at steady state (Cmax_ss)
Time frame: Day 1 & Day 14
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oral capsule/tablet, QD