NCT04150250 - Cholera Anti-Secretory Treatment Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 4, 2019

Primary Completion Date

July 27, 2020

Study Completion Date

July 27, 2020

Conditions

Cholera

Interventions

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)"

Trial Locations (1)

21201

Pharmaron, Baltimore