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A Study to Investigate the Safety and Tolerability of MK0517 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00990821
First received: October 6, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

This 5-part study will evaluate the safety and tolerability of MK0517, both PS80 and Non-PS80 formulations.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Postoperative Nausea and Vomiting
 Drug: MK0517
Drug: Comparator: aprepitant 40 mg
Drug: Comparator: midazolam
Drug: Comparator: aprepitant 125mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Plasma Area Under the Curve (AUC(0 to infinity)) for Aprepitant [ Time Frame: 72 Hours Post Dose ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: January 2005
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Part 1 - Panel A
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes

Drug: Comparator: aprepitant 125mg
a single dose of 125 mg oral aprepitant
Experimental: 2
Part 1 - Panel B
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes

Drug: Comparator: aprepitant 125mg
a single dose of 125 mg oral aprepitant
Experimental: 3
Part 1 - Panel C
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes

Drug: Comparator: aprepitant 40 mg
a single dose of 40 mg oral aprepitant
Experimental: 4
Part II
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes

Drug: Comparator: midazolam
a single dose of 2 mg oral midazolam
Experimental: 5
Part III - Panel 1
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes

Drug: Comparator: aprepitant 125mg
a single dose of 125 mg oral aprepitant
Experimental: 6
Part III - Panel 2
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes
Experimental: 7
Part IV
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes
Experimental: 8
Part V
 Drug: MK0517

Part 1 - Panel A: 100 mg or 150 mg Non-PS80 formulation MK0517 by IV administered over 5 minutes

Part 1 - Panel B: 100 mg or 150 mg PS80 formulation MK0517 IV administered over 15 minutes

Part 1 - Panel C: 40 mg Non-PS80 formulation MK0517 by IV administered over 2 minutes

Part II: 100 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 1: 90 mg PS80 formulation MK0517 IV administered over 15 minutes

Part III - Panel 2: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part IV: 40 mg Non-PS80 formulation MK0517 IV administered over 30 seconds

Part V: 100 mg or 115 mg PS80 formulation MK0517 IV administered over 15 minutes

Drug: Comparator: aprepitant 125mg
a single dose of 125 mg oral aprepitant

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990821

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00990821     History of Changes
Other Study ID Numbers: 2009_671, MK0517-012
Study First Received: October 6, 2009
Last Updated: October 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Midazolam
Aprepitant
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013