NCT04809649

SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: George R Thompson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how safe, effective, and well tolerated a new investigational antifungal drug, SUBA-itraconazole, is for patients who have been previously treated with fluconazole and have had either an insufficient response to treatment with fluconazole or a negative reaction to fluconazole preventing their further treatment with it.

Detailed description

This is a prospective, multi-center, open-label study involving subjects with proven or probable coccidioidomycosis refractory to fluconazole therapy following \>40 days of treatment or subjects with proven or probable coccidioidomycosis who are intolerant to fluconazole. The availability "Super Bioavailability" (SUBA) itraconazole 65 mg capsules with twice-daily dosing options with improved pharmacokinetics and lack of food or acidity requirements offers a substantial opportunity to improve the treatment of subjects with coccidioidomycosis.

Conditions

• Coccidioidomycosis
• Valley Fever

Interventions

Type	Name	Description
DRUG	SUBA-itraconazole	Participant will receive treatment with SUBA-itraconazole

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-03-22
• Last updated: 2021-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study