check_circleStudy Completed

Chagas’ disease

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

Trial purpose

This study evaluated the effect of food on the absorption of the drug as well as safety and tolerability in adults suffering from chronic Chagas’ disease
In addition pharmacokinetics of the drug following 120 and 240 mg single doses will be assessed

Key Participants Requirements

Sex

All

Age

18 - 45 Years

Trial summary

Enrollment Goal
36
Trial Dates
June 2019 - January 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
Lampit (Nifurtimox, BAYA2502)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
FP Clinical PharmaBuenos Aires, C1431CEF, Argentina

Primary Outcome

  • AUC(0-tlast) of nifurtimox (evaluation of food effect)
    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, 3, 4, 6, 8,12,15 hour
  • Cmax of nifurtimox (evaluation of food effect)
    Peak concentrations (Cmax) of the plasma concentration vs time profiles
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour

Secondary Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs)
    Clinical Laboratory Test, physical examinations, vital signs and 12 electrocardiograms ( ECG’s) for safety and tolerability
    date_rangeTime Frame:
    Up to 8 weeks
  • AUC(0-tlast)/D of nifurtimox (evaluation of food effect)
    AUC(0-tlast)/D: AUC(0-tlast) divided by dose
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
  • Cmax/D of nifurtimox (evaluation of food effect)
    Cmax/D: Cmax divided by dose
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour

Trial design

Open-label, randomized, single-dose, cross-over study to evaluate the influence of dietary habits on the pharmacokinetics, safety, and tolerability of a 120 mg dose and to assess the relative bioavailability of a 240 mg dose of nifurtimox tablets administered to adult male and female patients with Chagas’ disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2