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

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ClinicalTrials.gov Identifier: NCT02285647
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.

Tracking Information
First Submitted Date  ICMJE September 25, 2014
First Posted Date  ICMJE November 7, 2014
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration [ Time Frame: 39-69 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
Cmax: observed maximum plasma concentration [ Time Frame: 39-69 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 4, 2014)
Tmax: observed time to reach Cmax [ Time Frame: 39-69 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Official Title  ICMJE An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Brief 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.
Detailed Description To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single intravenous dose of 185 mg rolapitant administered as an infusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Chemotherapy-induced Nausea and Vomiting
Intervention  ICMJE
  • 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)
    Other Name: Rolapitant
  • 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)
    Other Name: Rolapitant
Study Arms  ICMJE
  • Experimental: Rolapitant - Oral
    Investigational Product: Rolapitant Dose: 200 mg (4 x 50mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight)
    Intervention: Drug: Rolapitant - Oral
  • Experimental: Rolapitant - IV
    Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)
    Intervention: Drug: Rolapitant - IV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
138
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2014)
100
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must be healthy males or females aged 18 to 55 years (inclusive).
  2. Female subjects of childbearing potential must have a negative pregnancy test at the Screening visit and on Day -1.
  3. Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from 72 hours before admission to the clinical unit until study completion.
  4. Subjects must have a BMI from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥ 50 kg at the Screening visit.
  5. Subjects must be able to provide informed consent after risks and benefits have been explained. Subjects must be capable of understanding, able to sign a written informed consent and willing to comply with the protocol requirements.
  6. Subjects must be non-tobacco users (defined as a subject who has not smoked or used nicotine products in the last 90 days before administration of study drug) and have a negative cotinine test for nicotine at the Screening visit and Day -1.
  7. Subjects must agree to discontinue intake of alcohol and beverages or food known to interfere with CYP metabolic enzymes such as: grapefruit- and quinine-containing food and beverages (e.g., tonic water, bitter lemon), orange juice, prune juice, pomelos, cranberry, pomegranate, star fruit, Seville oranges (or marmalade made from them), garlic supplements, St. John's Wort or licorice from 72 hours before admission to the clinical unit until completion of the study.
  8. Subjects must be in general good health as determined by the Investigator, based on prestudy medical and surgical history, physical examination and clinical laboratory tests.
  9. Subjects must have cardiovascular (including 12-lead ECG) function at the Screening visit that has no clinically significant abnormalities as determined by the Investigator.

Exclusion Criteria:

  1. Subjects who have participated in another investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, before the time of first study dose.
  2. Subjects who have a history of hypersensitivity to rolapitant or any of its excipients or who have participated in a previous rolapitant study within 6 months before the time of first study drug dose administration dose (Day 1).
  3. Subjects who have a history of relevant allergies (including asthma, food or drug allergies), as determined by the Investigator.
  4. Subjects who have had significant blood loss, or have donated or received 1 or more units (450 mL) of blood within 30 days before the first study dose.
  5. Subjects who have received any prescription medications or over-the-counter (OTC) medications or herbal supplements within 14 days before the first study dose. By exception, acetaminophen ≤ 1 g/day is permitted.
  6. Subjects who have current or recent (within 1 year of the Screening visit) history of alcohol abuse, illicit drug use, physical dependence or addiction to alcohol or any opioid.
  7. Cholecystectomized subjects (since biliary excretion is a predominant mode of excretion with rolapitant).
  8. Subjects who have any clinical or psychiatric condition or prior therapy that, in the Investigator's opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
  9. Subjects who are unwilling or unable to avoid xanthine- and caffeine-containing drinks (including many soft drinks, energy drinks, coffee and tea) and foods (such as chocolate or coffee flavored) from 72 hours before admission through until the subjects are discharged on Day 39.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02285647
Other Study ID Numbers  ICMJE PR-11-5016-C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tesaro, Inc.
Study Sponsor  ICMJE Tesaro, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dennis Vargo, MD Tesaro, Inc.
PRS Account Tesaro, Inc.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP