Clinical trial NCT02285647: An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Official title: An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tesaro, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
timeFrame: 39-69 days
Secondary outcomes:
measure: Cmax: observed maximum plasma concentration
timeFrame: 39-69 days
Other outcomes:
measure: Tmax: observed time to reach Cmax
timeFrame: 39-69 days
Locations:
city: Baltimore
country: United States
facility: Parexel
state: Maryland
Study officials:
affiliation: Tesaro, Inc.
name: Dennis Vargo, MD
role: STUDY_DIRECTOR
References: