Clinical Trial: Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Non-blinded, Randomized, Single Center, Single Dose, Cross-over Study to Assess the Effect of a High Calorie/High Fat Meal on the Pharmacokinetics of Four 30 mg Nifurtimox Tablets Taken Orally by Adul

Brief Summary: This study will evaluate the effect of food on the absorption of the drug as well as safety and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering from chronic Chagas' disease when administered after a high-fat / high-calorie test meal (American breakfast) compared to a fasting state. This study is required as part of the clinical development of an age appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic countries according to the recommendations provided by current international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage Forms).

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

  • Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point[AUC(0-tlast)] [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]
  • Plasma concentration nifurtimox characterized by Cmax [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]
  • Plasma concentration of nifurtimox characterized by tmax [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]
  • Plasma concentration of nifurtimox characterized by AUC [ Time Frame: 0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 8 weeks ]

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: November 16, 2015
Date Started: December 2015
Date Completion:
Last Updated: November 11, 2016
Last Verified: November 2016