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

Phase 1

Completed

• Conditions: Chagas Disease
• Interventions: Drug: Nifurtimox (Lampit, BAYA2502)

• Registration Number: NCT03350295
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Primary objective is to assess the relative bioavailability of three formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles (slow, medium, and fast, whereby "medium" represents the drug product currently used in clinical Phase 3 studies) under fed conditions in adult male and female patients with Chagas' disease.

A secondary objective of the study is to assess the relative bioavailability of nifurtimox after a single oral dose of 30 mg and 120 mg To assess the pharmacokinetics (PK) of nifurtimox To investigate the safety and tolerability of nifurtimox..

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-22
• Study Start: 2018-06-14
• Primary Completion: 2018-09-18
• Study Completion: 2018-12-14
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GRP2 - Assess relative bioavailability (2-way cross-over)	Nifurtimox (Lampit, BAYA2502)	GROUP 2 (Treatments D and E) Participants received the 2 treatments in one of two treatment sequences under fed condition. Treatment D, a single dose 30 mg nifurtimox dose with medium in vitro dissolution characteristics Treatment E, a single dose of 120 mg nifurtimox
GRP1 - Assess relative bioavailability(3-way cross-over)	Nifurtimox (Lampit, BAYA2502)	GROUP 1 (Treatments A, B, C) All 3 treatments in Group 1 consist of a dose of 120 mg nifurtimox (4 x 30 mg tablets). Participants received the 3 treatments in one of six treatment sequences under fed condition. Treatment A, dose administration with fast in vitro dissolution characteristics Treatment B, dose administration with medium in vitro dissolution characteristics Treatment C, dose administration with slow in vitro dissolution characteristics

Primary Outcome Measures

Name	Time	Method
AUC(0-tlast) of nifurtimox	0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour	AUC(0-tlast):Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point
Cmax of nifurtimox	0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour	Cmax: Maximum observed drug concentration in measured matrix after single dose administration
AUC of nifurtimox	0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour	AUC: Area under the concentration versus time curve from zero to infinity after single (first) dose

Secondary Outcome Measures

Name	Time	Method
AUC divided by dose: AUC/D	0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
Number of participants with adverse events	up to 8 weeks
AUC(0-tlast) divided by dose: AUC(0-tlast)/D	0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour
Cmax divided by dose: Cmax/D	0, 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,15 hour

Trial Locations

Locations (1)

FP Clinical Pharma; 🇦🇷 Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina