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An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant

NCT02285647 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2015-08-25

No results posted yet for this study

Summary

This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Rolapitant - Oral

Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight)

DRUG

Rolapitant - IV

IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)

Sponsors & Collaborators

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Vargo, MD · Tesaro, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02285647 on ClinicalTrials.gov