NCT01823939

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diarrhea
• Cholera

Interventions

Type	Name	Description
DRUG	iOWH032	Part A: Participants will be randomized at a 3:1 ratio to receive treatment with iOWH032 or placebo. A randomisation code will be generated. Each participant will be assigned the next participant number available and thereby will be assigned randomly. Active treatment will consist of an oral tablet containing 300 mg of iOWH032. The placebo will consist of identical looking tablets. Part B: There will be no randomization during this trial. All eligible patients will receive 300 mg of iOWH032.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-11-01
• Completion: 2014-12-01
• First posted: 2013-04-04
• Last updated: 2015-06-11

Locations

1 site across 1 country: Bangladesh