check_circleStudy Completed

Chagas Disease

Study to assess the food effect on the pharmacokinetics of nifurtimox tablets in chronic Chagas’ patients

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 - 45 Years

Trial summary

Enrollment Goal
36
Trial Dates
December 2015 - August 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Lampit (Nifurtimox, BAYA2502)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Buenos Aires, C1425BAB, Argentina

Primary Outcome

  • Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point[AUC(0-tlast)]
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration nifurtimox characterized by Cmax
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of nifurtimox characterized by tmax
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of nifurtimox characterized by AUC
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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 adult male and female patients suffering from chronic Chagas’ disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2