The Pharmacokinetic Interaction Between Oral Casopitant and Oral Dolasetron, Granisetron or Rosiglitazone in Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00511823
First received: August 2, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

This A Three-Part Drug-Drug Interaction Study To Evaluate Effects of Casopitant On Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adults


Condition Intervention Phase
Postoperative Nausea and Vomiting
Nausea and Vomiting, Chemotherapy-Induced
Chemotherapy-Induced Nausea and Vomiting
Drug: casopitant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Three-Part, Two Period, Single Sequence Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Repeat Oral Doses of Dolasetron, Granisetron or Rosiglitazone When Co-Administered in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change of AUC and Cmax of dolasetron, granisetron and rosiglitazone after oral administration alone and co-administered with oral casopitant [ Time Frame: (comparing AUC & Cmax of Days 1&3 of the Period One and Two) ]

Secondary Outcome Measures:
  • Safety evaluations of AEs and changes in laboratory values, ECGs, vitals evaluated during the study [ Time Frame: (Day -1 and Days 1-4 of the Period One and Two, at follow-up visit) ]

Enrollment: 16
Study Start Date: July 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: casopitant
    Other Name: casopitant
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • An adult healthy male or female.
  • Age: 18 to 64 years, inclusive.
  • Body mass index (BMI) = 19 to = 37 kg/m2.
  • A female if she is of Non-childbearing potential, OR
  • A female who has a negative serum pregnancy test within 14 days prior to the first dose of study medication and agrees to use adequate contraception during the study and for 14 days after the last dose of study medication.
  • Adequate organ systems function [Hemoglobin is within normal limits ± 10%; Platelets is = 100 X 109/L or = lower limit of normal (LLN); Aspartate aminotransaminase = Upper limit of normal (ULN); Total bilirubin = 1.2 times ULN; Creatine phosphokinase < 1.5 times ULN; Renal Calculated creatinine clearance = 50 mL/min]
  • Able to swallow and retain oral medication.
  • Able to understand and comply with the requirements, instruction and restrictions stated in the informed consent.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Clinically relevant abnormality, including any degree of heart failure or clinically significant cardiac disease, identified on the screening exam or any other medical condition or circumstance making the subject unsuitable for participation in the study.
  • For Part A (dolasetron-casopitant drug-drug interaction), any subject who exhibits gene duplication for CYP2D6.
  • History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
  • Known immediate hypersensitivity reaction or idiosyncrasy to study drugs or any drug chemically related to the study medications.
  • Use of an investigational drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of study medication(s).
  • Blood donation in excess of 500 mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
  • Presence of or suspected iron deficiency.
  • Stool positive for occult blood.
  • Troponin I level above 10% of the coefficient of variation of the assay.
  • For female subjects of childbearing potential, a positive serum pregnancy test.
  • Female subject who is lactating.
  • Positive urine drug screen (UDS) including alcohol.
  • Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen (HBsAg).
  • Positive urinary cotinine.
  • Smoking history of = 4 packs per day/year or smoked more than 2 times within the past 30 days prior to screening.
  • History of drug abuse or dependence within 6 months of screening.
  • History of alcohol abuse within 6 months of screening or alcohol consumption in the past 6 months exceeding 7 drinks/week for women and 14 drinks/week for men (where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
  • Presence of an active infection.
  • Corrected QT interval (QTc) > 450 msecs.
  • Pepsinogen level below the lower limit of laboratory reference range (LLRR).
  • Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
  • Use of any prescription or non-prescription drug(s), including oral contraceptives, herbal or dietary supplements or vitamins within 14 days, or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Consumption of food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pomelos, star fruit, red wine, charbroiled meats, cabbage or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) within 7 days prior to the first dose of study medication(s).
  • History of cholecystectomy or biliary tract disease.
  • Any serious or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511823

Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00511823     History of Changes
Other Study ID Numbers: NKV110483
Study First Received: August 2, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
drug-drug interaction,
rosiglitazone,
safety
CYP2C8,
pharmacokinetics,
CYP3A4,
granisetron,
dolasetron,
CYP2D6,
casopitant,

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Granisetron
Dolasetron mesylate
Rosiglitazone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 26, 2014