A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers

NCT02382666 | Completed Phase 1

• 1 other identifier: PR-11-5022-C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  : 0-30 days after administration of study drug

Secondary Outcomes (2)

• 1. AUC0-last: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration

  0-21 days

• 2. Cmax = observed maximum plasma concentration

  0-21 days

Study Arms (6)

Rolapitant Cohort 1

EXPERIMENTAL

Investigational Product: Rolapitant Dose 1 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution

Drug: Rolapitant

Rolapitant Cohort 2

EXPERIMENTAL

Investigational Product: Rolapitant Dose 2 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution

Drug: Rolapitant

Rolapitant Cohort 3

EXPERIMENTAL

Investigational Product: Rolapitant Dose 3 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution

Drug: Rolapitant

Rolapitant Cohort 4

EXPERIMENTAL

Investigational Product: Rolapitant Dose 4 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution

Drug: Rolapitant

Rolapitant Cohort 5

EXPERIMENTAL

Investigational Product: Rolapitant Dose 5 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution

Drug: Rolapitant

Rolapitant Cohort 6

EXPERIMENTAL

Investigational Product: Rolapitant Dose 6 administered IV as a 30-minute infusion Dosage Form: 2 mg/mL solution

Drug: Rolapitant

Interventions

Rolapitant DRUG

Rolapitant Cohort 1; Rolapitant Cohort 2; Rolapitant Cohort 3; Rolapitant Cohort 4; Rolapitant Cohort 5; Rolapitant Cohort 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tesaro, Inc.: lead

Study Sites (1)

Parexel

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

rolapitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Vargo, MD

  Tesaro, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (1)