This is a Phase 1, 2-part double-blinded (with respect to NX-5948/placebo), placebo-controlled study. Part 1 is a randomized, 3 period cross-over food-effect (FE) and drug-drug interaction (DDI) study. Part 2 is a single-period PK evaluation study.
Part 1: Periods 1 and 2: Subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio. In each treatment sequence, subjects will be randomized to receive either active NX-5948 or placebo in a 7:2 ratio. Subjects will receive a single dose of NX-5948 or placebo under fasting or fed conditions as per randomization schedule to evaluate the effect of food on the single- dose pharmacokinetics (PK) of NX-5948 in healthy subjects. Period 3: Fluconazole will be administered every day for 8 consecutive days with a single dose of NX-5948/placebo coadministered on Day 4 to evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects. Part 2: Subjects will be randomized to receive either active NX-5948 or placebo to assess single-period PK. Parts 1 and 2: Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
NX-5948 oral
Fluconazole
Celerion
Lincoln, Nebraska, United States
Part 1 Food Effect: AUC0-t for NX-5948 administered under fed and fasted conditions
To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.
Time frame: 9 weeks
Part 1 Food Effect: AUC0-inf for NX-5948 administered under fed and fasted conditions
To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.
Time frame: Approximately 9 weeks
Part 1 Food Effect: Cmax for NX-5948 administered under fed and fasted conditions
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
Time frame: 9 weeks
Part 1 Drug Drug Interaction: AUC0-inf for NX-5948 administered with and without fluconazole
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
Time frame: 9 weeks
Part 1 Drug Drug Interaction: Cmax for NX-5948 administered with and without fluconazole
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
Time frame: 9 weeks
Part 1 Drug Drug Interaction: AUC0-t for NX-5948 administered with and without fluconazole
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
Time frame: Approximately 9 weeks
Part 2 PK: AUC0-inf for NX-5948 administration
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
Time frame: 6 weeks
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Part 2 PK: Cmax for NX-5948 administration
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
Time frame: 6 weeks
Part 2 PK: AUC0-t for NX-5948 administration
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
Time frame: Approximately 6 weeks
Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate safety and tolerability of single doses of NX-5948 administered alone under fed and fasting conditions and following multiple doses of fluconazole in healthy subjects.
Time frame: Approximately 9 weeks
Part 2: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate safety and tolerability of 2 doses of NX-5948 given 12 hours apart in healthy subjects.
Time frame: Approximately 6 weeks