Clinical trial NCT02382666: A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
Official title: A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tesaro, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Part 1 Dose Escalation: Safety and Tolerability (adverse events)
timeFrame: 0-30 days after administration of study drug
measure: Part 2 Dose Treatment: Safety and Tolerability (adverse events)
timeFrame: : 0-30 days after administration of study drug
Secondary outcomes:
measure: 1. AUC0-last: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
timeFrame: 0-21 days
measure: 2. Cmax = observed maximum plasma concentration
timeFrame: 0-21 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Parexel
state: Maryland
Study officials:
affiliation: Tesaro, Inc.
name: Dennis Vargo, MD
role: STUDY_DIRECTOR
References: