Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06593457 | A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects | PHASE1 | COMPLETED | 32 | — | — | Aug 20, 2024 | Nov 14, 2024 | Mar 14, 2025 | 1 | United States |
To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.
To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Part 1: Sequence 1 (Treatment A, B, C) | EXPERIMENTAL | Period 1: NX-5948 or placebo administered under fasted conditions Period 2: NX-5948 or placebo administered under fed conditions Period 3: Fluconazole and single dose of NX-5948/placebo coadministered on Day 4 |
| Part 1: Sequence 2 (Treatment B, A, C) | EXPERIMENTAL | Period 1: NX-5948 or placebo administered under fed conditions Period 2: NX-5948 or placebo administered under fasted conditions Period 3: Fluconazole and single dose of NX-5948/placebo coadministered on Day 4 |
| Part 2: NX-5948 PK | EXPERIMENTAL | Experimental: Part 2: NX-5948 PK NX-5948 or placebo administered 2 doses given 12 hours apart under fasted conditions |
| Name | Type | Description |
|---|---|---|
| IP | DRUG | NX-5948 oral |
| Matching Placebo | DRUG | Fluconazole |
Inclusion Criteria: Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study: * Healthy, adult, male, 18-55 years of age * Subjects must follow protocol-specified contraception guidance as described in the protocol. * Continuous non-smoker who has...