The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.
This study aims to evaluate the safety and tolerability of 5 days of albaconazole dosing at levels that exceed both the projected therapeutic dose and the projected therapeutic frequency, in order to identify an upper dose for administration in a TQTc study. It also aims to assess the pharmacokinetics of multiple escalating doses of albaconazole, and to assess the effects of multiple and sustained dosing of high doses of albaconazole on ECG parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
24
Albaconozole 400 mg oral once daily for 5 days
Placebo oral once daily for 5 days
Albaconozole 400 mg every 12 hours for 5 days
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States
Plasma concentrations of albaconazole in subjects
Time frame: During 5 days of dosing and 15 days follow-up
Electrocardiogram (ECG) QTc values
Time frame: During 5 days of dosing and 15 days follow-up
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Placebo oral every 12 hours for 5 days
Albaconozole 400 mg oral every 8 hours for 5 days
Placebo oral every 8 hours for 5 days