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IP

Phase 1

Healthy Volunteers | Small molecule | Other |Nurix Therapeutics, Inc.|Last Updated: Mar 14, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

IP · 1 trial · 1 indication

Phase 1 1
NCT06593457A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult SubjectsHealthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects
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Study Endpoints

Primary Endpoints

Part 1 Food Effect: AUC0-t for NX-5948 administered under fed and fasted conditions
9 weeks

To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.

Part 1 Food Effect: AUC0-inf for NX-5948 administered under fed and fasted conditions
Approximately 9 weeks

To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.

Part 1 Food Effect: Cmax for NX-5948 administered under fed and fasted conditions
9 weeks

To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

Part 1 Drug Drug Interaction: AUC0-inf for NX-5948 administered with and without fluconazole
9 weeks

To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

Part 1 Drug Drug Interaction: Cmax for NX-5948 administered with and without fluconazole
9 weeks

To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

Part 1 Drug Drug Interaction: AUC0-t for NX-5948 administered with and without fluconazole
Approximately 9 weeks

To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

Part 2 PK: AUC0-inf for NX-5948 administration
6 weeks

To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.

Part 2 PK: Cmax for NX-5948 administration
6 weeks

To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.

Part 2 PK: AUC0-t for NX-5948 administration
Approximately 6 weeks

To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.

Secondary Endpoints

Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Approximately 9 weeks
Part 2: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Approximately 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Sequence 1 (Treatment A, B, C)EXPERIMENTALPeriod 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)EXPERIMENTALPeriod 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 PKEXPERIMENTALExperimental: Part 2: NX-5948 PK NX-5948 or placebo administered 2 doses given 12 hours apart under fasted conditions

Interventions

NameTypeDescription
IPDRUGNX-5948 oral
Matching PlaceboDRUGFluconazole
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about IP

What is IP?

IP is an investigational small molecule being developed by Nurix Therapeutics, Inc. (NASDAQ: NRIX). It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy volunteers, with the trial focusing on food effects, drug-drug interactions, and pharmacokinetics.

What is IP used for?

IP is being studied for use in healthy volunteers. The completed Phase 1 clinical trial (NCT06593457) was designed to evaluate the food effect, drug-drug interaction potential, and pharmacokinetics of IP in healthy adult subjects. The drug is not approved for any indication and remains in clinical development.

Who makes IP?

IP is developed by Nurix Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NRIX. Nurix is conducting clinical research on IP as an investigational small molecule.

What phase is IP in?

IP is in Phase 1 clinical development. The drug has completed one Phase 1 trial (NCT06593457) that enrolled 32 healthy male participants in the United States. IP is investigational and has not been approved by regulatory authorities.

What clinical trials is IP in?

IP has been studied in one completed Phase 1 clinical trial, NCT06593457, titled 'A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects.' The trial enrolled 32 healthy male volunteers aged 18 years and older in the United States.

Is IP the same as NX-5948?

Yes, IP is also known as NX-5948. The clinical trial record for IP, NCT06593457, refers to the drug as NX-5948 in its title. Both names refer to the same investigational small molecule being developed by Nurix Therapeutics.