PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera — PISCES  

Diarrhea Clinical Trial

Official title: Two-Part, Single-Centre Pharmacokinetic Study of iOWH032 in Adult Male and Female Healthy Volunteers, and Adult Males With Cholera

Status Completed

Clinical Trial Summary

This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients. This is not a hypothesis-driven research study.

Clinical Trial Description

This study will be conducted in two parts.

The first part (Part A) will evaluate the pharmacokinetics, safety and tolerability of iOWH032 in healthy, adult Bangladeshi volunteers.

The second part (Part B) will evaluate the pharmacokinetics, safety and tolerability of iOWH032 in adult Bangladeshi patients with cholera. While female participants will be included in Part A, only male patients will be enrolled in Part B. The rationale for excluding women in Part B is the difficulty in separating urine from stool in severely dehydrated females with rapid rates of purging. Moreover, it has been difficult to retain adult females in the hospital after improvement of their diarrhoea because of their household responsibilities, which might impact compliance in this small study. Further, no sex differences in the pharmacokinetics of iOWH032 were found in the study conducted in healthy subjects in the US, which included 42 males and females, nor have sex differnces been observed in preclinical studies. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholera
• Diarrhea

• NCT number: NCT01823939
• Study type: Interventional
• Source: PATH
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Completion date: December 2014