Healthy VolunteersPhase 1NCT06593457
A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects
A Phase 1 study testing IP in people with Healthy Volunteers, run by Nurix Therapeutics, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 14 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and 12-lead safety ECGs, at the screening visit and/or first check-in, as deemed by the PI or designee,
- Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
Who cannot join
- Subjects must not be enrolled in the study if they meet any of the following criteria:
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic (including leukemia, lymphoma, malignant melanoma), myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders, or any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subjects by their participation in the study.
- History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds.
- History or presence of:
- Significant multiple and/or severe allergies, including anaphylactic reaction.
- Risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome, or sudden unexpected cardiac death at a young age).
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- Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.
- Myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, clinically significant ventricular or atrial tachyarrhythmia as determined by the PI or designee, documented syncope without identified and corrected cause, a pacemaker or implantable cardioverter-defibrillator, cardiac or carotid/cerebral stent placement or angioplasty, or clinically significant valvular heart disease.
- Adrenal insufficiency.
- Skin infection.
- Positive Coronavirus disease 2019 (COVID-19) results at first check-in.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
- Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements (including kava, ginko biloba, yohimbe, and saw palmetto) beginning 14 days prior to the first dosing.
- Any drugs known to be moderate or strong inducers and inhibitors of CYP3A4, P gp, and/or breast cancer resistance protein, including St. John's Wort, dehydroepiandrosterone, and ginseng, beginning 28 days prior to the first dosing.
- Any acid reducing agents beginning 7 days prior to the first dosing.
- Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part, Placebo-Controlled, Double-Blinded Study to Assess the Effect of Food and Drug-Drug Interaction of Fluconazole on the Pharmacokinetics of NX-5948
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- IP, Matching Placebo
- Keywords
- Drug-Drug Interaction, Food effects, Healthy participants, Pharmacokinetics, Pharmacodynamics, NX-5948, BTK Degrader
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPDrug
NX-5948 oral
Matching PlaceboDrug
Fluconazole
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: IP; Drug: Matching Placebo |
| 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 Receives: Drug: IP; Drug: Matching Placebo |
| 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 Receives: Drug: IP; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
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.
Measured: 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.
Measured: Approximately 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Aug 2024
- Primary completion29 Oct 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Injac, MD PhD, Study director, Nurix Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593457
- Sponsor's protocol ID
- NX-5948-302
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Placebo-Controlled, Double-Blinded Study to Assess the Effect of Food and Drug-Drug Interaction of Fluconazole on the Pharmacokinetics of NX-5948
- ClinicalTrials.gov ID
- NCT06593457
- Acronym / sponsor ID
- NX-5948-302
- Conditions
- Healthy Volunteers
- Keywords
- Drug-Drug Interaction, Food effects, Healthy participants, Pharmacokinetics, Pharmacodynamics, NX-5948, BTK Degrader
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nurix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Sequence 1 (Treatment A, B, C) | Experimental | Drug: IP, Drug: Matching PlaceboPeriod 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 | Drug: IP, Drug: Matching PlaceboPeriod 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 | Drug: IP, Drug: Matching PlaceboExperimental: Part 2: NX-5948 PK NX-5948 or placebo administered 2 doses given 12 hours apart under fasted conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
Key exclusion criteria (17 listed)
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic (including leukemia, lymphoma, malignant melanoma), myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders, or any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subjects by their participation in the study.
- History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds.
- History or presence of:
- Positive Coronavirus disease 2019 (COVID-19) results at first check-in.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPNX-5948 oral | Drug | Part 1: Sequence 1 (Treatment A, B, C), Part 1: Sequence 2 (Treatment B, A, C), Part 2: NX-5948 PK |
| Matching PlaceboFluconazole | Drug | Part 1: Sequence 1 (Treatment A, B, C), Part 1: Sequence 2 (Treatment B, A, C), Part 2: NX-5948 PK |
Primary outcome
Part 1 Food Effect: AUC0-t for NX-5948 administered under fed and fasted conditions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Approximately 6 weeks
To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.
2 secondary outcomes
Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Approximately 9 weeks
Part 2: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Approximately 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Injac, MD PhD study director
Nurix Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IP in people with Healthy Volunteers, run by Nurix Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Food Effect: AUC0-t for NX-5948 administered under fed and fasted conditions (time frame: 9 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.