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

August 2, 2007
May 31, 2012
July 2007
September 2007   (final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT00511823 on ClinicalTrials.gov Archive Site
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) ]
Same as current
Not Provided
Not Provided
 
The Pharmacokinetic Interaction Between Oral Casopitant and Oral Dolasetron, Granisetron or Rosiglitazone in Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postoperative Nausea and Vomiting
  • Nausea and Vomiting, Chemotherapy-Induced
  • Chemotherapy-Induced Nausea and Vomiting
Drug: casopitant
Other Name: casopitant
Not Provided
Adams LM, Johnson B, Zhang K, Yue L, Kirby LC, Lebowitz P, Stoltz R. Effect of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of dolasetron and granisetron. Support Care Cancer. 2009 Sep;17(9):1187-93. Epub 2009 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00511823
NKV110483
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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