check_circleStudy Completed

Chagas Disease

Study will evaluate the relative bioavailability, safety, and tolerability of single doses of nifurtimox 30 mg tablets exhibiting different in vitro dissolution characteristics, and to evaluate the relative bioavailability of nifurtimox 30 mg and 120 mg

Trial purpose

Study to assess the relative Bioavailability
To assess the relative bioavailability of three formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles
To assess the pharmacokinetics (PK) of nifurtimox
To investigate the safety and tolerability of nifurtimox.

Key Participants Requirements

Sex

Both

Age

18 - 45 Years

Trial summary

Enrollment Goal
48
Trial Dates
June 2018 - December 2018
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, C1425BAB, Argentina

Primary Outcome

  • AUC(0-tlast) of nifurtimox
    AUC(0-tlast):Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
  • Cmax of nifurtimox
    Cmax: Maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
  • AUC of nifurtimox
    AUC: Area under the concentration versus time curve from zero to infinity after single (first) dose
    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 adverse events
    date_rangeTime Frame:
    up to 8 weeks
  • AUC divided by dose: AUC/D
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
  • AUC(0-tlast) divided by dose: AUC(0-tlast)/D
    date_rangeTime Frame:
    0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
  • Cmax divided by dose: Cmax/D
    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 relative bioavailability, safety, and tolerability of single doses of nifurtimox 30 mg tablets exhibiting different in vitro dissolution characteristics, and to evaluate the relative bioavailability of nifurtimox 30 mg and 120 mg 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