Skip to main content
OpenTrials
Completed

NCT Number: NCT00990821

A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)

This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is neither grossly overweight nor underweight for his/her height and body build
  • Subject is in good health -Subject is a nonsmoker
  • Subject is willing to avoid excessive alcohol consumption for the duration of the study
  • Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
  • Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

Exclusion criteria

  • Subject has a history of multiple and/or severe allergies to drugs or food
  • Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
  • Subject has an infection, including Human immunodeficiency virus (HIV) infection
  • Subject is a regular user of any illicit drug
  • Subject consumes excessive amounts of alcohol
  • Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
  • Subject currently uses on a regular basis, any prescription or non prescription medications

Treatment and study plan

90 mg MK-0517 (PS80)

Drug

MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes

100 mg MK-0517 (PS80)

Drug

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

100 MK-0517 (PS80) + 2 mg midazolam

Drug

MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.

115 mg MK-0517 (PS80)

Drug

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

150 mg MK-0517 (PS80)

Drug

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

40 mg MK-0517 (non-PS80)

Drug

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

100 mg MK-0517 (non-PS80)

Drug

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

150 mg MK-0517 (Non-PS80)

Drug

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

Placebo

Drug

Placebo matching MK-0517

40 mg Aprepitant

Drug

Aprepitant, oral, tablet, single dose

125 mg Aprepitant

Drug

Aprepitant oral tablet, single dose

2 mg Midazolam

Drug

Midazolam oral tablet, single dose

Primary outcomes

  1. Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V

    Time frame: Up to 72 Hours Post Dose

    AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Oct 7, 2009
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.