NCT03334838

Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary objective was to evaluate the effect of various food compositions on the PK of nifurtimox after a single oral dose (120 mg) administered under 3 types of fed conditions (low fat, dairy products, and high calorie and high fat), as well as fasted conditions, to assess relative bioavailability. It was chosen to allow a direct inter-study comparison of PK data obtained in previous studies. A secondary objective of the study was to assess the relative bioavailability of 2 different dose levels of nifurtimox, given as a single oral dose, in a second group of patients.The second treatment group addressed a biopharmaceutical aspect for which no study data have been obtained to date. In order to assess the relationship between dose and exposure (linearity of PK), an analysis of the dose range of 120 mg to 240 mg was chosen to close the knowledge gap for this dose range.

Conditions

• Chagas' Disease

Interventions

Type	Name	Description
DRUG	Nifurtimox (Lampit, BAYA2502)	Oral Intake of 4 x 30 mg nufurtimox tablets for treatment A-D; Oral Intake of 8 x 30 mg nufurtimox tablets for treatment E.

Timeline

• Start date: 2019-06-10
• Primary completion: 2019-11-07
• Completion: 2020-01-29
• First posted: 2017-11-07
• Last updated: 2020-12-30

Locations

1 site across 1 country: Argentina