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