check_circleStudy Completed
Chagas’ disease
Bayer Identifier:
16006
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
In addition pharmacokinetics of the drug following 120 and 240 mg single doses will be assessed
Key Participants Requirements
Sex
AllAge
18 - 45 YearsTrial summary
Enrollment Goal
36Trial Dates
June 2019 - January 2020Phase
Phase 1Could I Receive a placebo
NoProducts
Lampit (Nifurtimox, BAYA2502)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | FP Clinical Pharma | Buenos 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 profilesdate_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 tolerabilitydate_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 dosedate_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 dosedate_rangeTime Frame:0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2