NCT04150250

Cholera Anti-Secretory Treatment Trial

A Phase 2a Randomized, Single-Center, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Preliminary Efficacy of Oral iOWH032 Against Cholera Diarrhea in a Controlled Human Infection Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This trial was designed to assess safety and preliminary efficacy of oral doses of iOWH032 on diarrhea output and clinical symptoms after a cholera challenge in healthy adult participants.

Detailed description

The study consists of a screening phase, an inpatient containment period with challenge with Vibrio cholerae on Day 1 followed by treatment with iOWH032 or placebo and a post-challenge observation period until discharge, an outpatient follow-up period of at least 28 days, and a final follow-up (by telephone) 6 months post-challenge (Day 180) for the collection of serious adverse events. Participants will be randomized 1:1 to receive either iOWH032 500 mg every 8 hours for three days or matching placebo. Blinded therapeutic dosing will start at the onset of diarrhea or by 48 hours after ingesting the challenge inoculum of V. cholerae. The observation and management of cholera diarrhea and symptomatology will occur on an inpatient isolation research ward over a duration of approximately 11 days, including a three-day course of antibiotics to treat all participants prior to discharge from the inpatient unit.

Conditions

• Cholera

Interventions

Type	Name	Description
DRUG	iOWH032	Anti-secretory synthetically manufactured small molecule designed to inhibit the cystic fibrosis transmembrane conductance regulator chloride channel.
DRUG	Placebo	Oral tablets matching iOWH032 on taste, appearance, dissolution time with the same excipients but no active ingredients.
OTHER	V. cholerae Challenge	Freshly-harvested, wild-type Vibrio (V.) cholerae El Tor Inaba strain N16961,10\^6 cfu suspended in 30 mL of sodium bicarbonate solution ingested orally.
DRUG	Antibiotics	Antibiotic therapy may include: * Ciprofloxacin 500 mg, twice daily; * Azithromycin 500 mg, once daily (for those persons who are allergic to fluoroquinolones); * Doxycycline 300 mg, once daily (for those persons who are allergic to fluoroquinolones)

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-07-27
• Completion: 2020-07-27
• First posted: 2019-11-04
• Last updated: 2021-03-25
• Results posted: 2021-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study