Expired Study
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Baltimore, Maryland 21225


Purpose:

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.


Study summary:

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.


Criteria:

Main Inclusion Criteria: - Subject must be a healthy male or female aged 18 to 55 years at Screening - A female subject must have a negative pregnancy test at Screening and on Day -1. - A female subject of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from Screening through 30 days after final study drug administration. - Subject must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 and a weight of ≥ 50 kg at Screening. - Subject must be able to provide informed consent after risks and benefits have been explained. Subject must also be willing and able to comply with the protocol requirements. - Subject must be in general good health as determined by the Investigator based on pre-study medical, medication, and surgical history; physical examination; and clinical laboratory tests. Main Exclusion Criteria: - Subject must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose. - Subject must not have a history of hypersensitivity to rolapitant IV or any of its excipients or who have completed a study visit as part of a previous rolapitant study within the 6 months prior to first study drug administration (Day - Subject must not have poor venous access or consider venipuncture intolerable. - Subject must not have a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject unable to complete dosing requirements. - Subject must not be pregnant or lactating.


NCT ID:

NCT02382666


Primary Contact:

Study Director
Robert Martell, MD, PhD
Tesaro, Inc.


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21225
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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