Back to resultsA Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rolapitant
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting
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.
Sites / Locations
- Parexel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Rolapitant Cohort 1
Rolapitant Cohort 2
Rolapitant Cohort 3
Rolapitant Cohort 4
Rolapitant Cohort 5
Rolapitant Cohort 6
Arm Description
Investigational Product: Rolapitant Dose 1 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Investigational Product: Rolapitant Dose 2 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Investigational Product: Rolapitant Dose 3 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Investigational Product: Rolapitant Dose 4 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Investigational Product: Rolapitant Dose 5 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Investigational Product: Rolapitant Dose 6 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
1. AUC0-last: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
2. Cmax = observed maximum plasma concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02382666
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tesaro, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rolapitant Cohort 1
Arm Type
Experimental
Arm Description
Investigational Product: Rolapitant Dose 1 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Arm Title
Rolapitant Cohort 2
Arm Type
Experimental
Arm Description
Investigational Product: Rolapitant Dose 2 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Arm Title
Rolapitant Cohort 3
Arm Type
Experimental
Arm Description
Investigational Product: Rolapitant Dose 3 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Arm Title
Rolapitant Cohort 4
Arm Type
Experimental
Arm Description
Investigational Product: Rolapitant Dose 4 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Arm Title
Rolapitant Cohort 5
Arm Type
Experimental
Arm Description
Investigational Product: Rolapitant Dose 5 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Arm Title
Rolapitant Cohort 6
Arm Type
Experimental
Arm Description
Investigational Product: Rolapitant Dose 6 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution
Intervention Type
Drug
Intervention Name(s)
Rolapitant
Primary Outcome Measure Information:
Title
Part 1 Dose Escalation: Safety and Tolerability (adverse events)
Description
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
Title
Part 2 Dose Treatment: Safety and Tolerability (adverse events)
Description
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
Secondary Outcome Measure Information:
Title
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
Title
2. Cmax = observed maximum plasma concentration
Time Frame
0-21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Vargo, MD
Organizational Affiliation
Tesaro, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Parexel
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
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