The purpose of this study is to assess the safety and tolerability of single increasing doses of intravenously administered rolapitant in healthy male and female subjects.
Part 1 of the study is designed to evaluate the safety and tolerability of a SAD, up to 6 cohorts,of rolapitant IV (2 mg/mL solution) administered as an IV infusion over 30 minutes. In Part 2 of the study, the safety and tolerability of the highest safe and well-tolerated dose established in Part 1 will be evaluated in an expanded cohort. The highest safe and well-tolerated dose established in Part 1 will be ascertained by the following criteria: an upper limit of 90% confidence interval (CI) for Cmax. A minimum of 40 subjects will be enrolled in Part 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Parexel
Baltimore, Maryland, United States
Part 1 Dose Escalation: Safety and Tolerability (adverse events)
To evaluate the safety and tolerability of rolapitant IV (30 minutes infusion) in healthy adult volunteers as assessed by the incidence and severity of AEs
Time frame: 0-30 days after administration of study drug
Part 2 Dose Treatment: Safety and Tolerability (adverse events)
To evaluate the safety and tolerability of rolapitant IV (30 minutes infusion) to an expanded cohort of healthy adult volunteers at the highest safe and well-tolerated dose established in Part 1 as assessed by the incidence and severity of AEs.
Time frame: : 0-30 days after administration of study drug
1. AUC0-last: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: 0-21 days
2. Cmax = observed maximum plasma concentration
Time frame: 0-21 days
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