Healthy VolunteerPhase 1NCT06717269
A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers
A Phase 1 study testing NX-5948, Esomeprazole and Famotidine in people with Healthy Volunteer, run by Nurix Therapeutics, Inc. at 2 sites in United States.
Trial summary
This is a multiple part, multiple cohort study evaluating single and multiple ascending doses, relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- NX-5948, Esomeprazole and Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2024to 1 May 2026
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female 19-55 years of age
- Continuous non-smoker who has not used nicotine and tobacco-containing products for at least 3 months prior to the first dosing
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, or vital signs at the screening visit, as deemed by the Principal Investigator (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
- Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
- History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948
- History or presence of alcohol or drug abuse within the past 2 years
- History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds
- History or presence of:
Show all 20Show fewer
- Significant multiple and/or severe allergies, including anaphylactic reaction.
- Personal or family history of prolonged QT syndrome or family history of sudden cardiac death.
- Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff Parkinson-White Syndrome, or cardiac pacemaker.
- Adrenal insufficiency.
- Skin infection.
- Female volunteers of childbearing potential
- Female volunteer with a positive pregnancy test
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit
- Donation of blood or significant blood loss within 56 days prior to the first dosing
- Plasma donation within 7 days prior to the first dosing
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- Previous exposure to NX-5948.
- 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.
- Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Celerion
Phoenix, Arizona, 85283
About this study
Official title: A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules
This is a multiple part, multiple cohort study evaluating single and multiple ascending doses, relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- NX-5948, Esomeprazole, Placebo, Famotidine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-5948Drug
Also called Bexobrutideg
Administered orally in tablet or capsule form
EsomeprazoleDrug
Administered orally in capsule form
PlaceboDrug
Administered orally matching NX-5948 tablets
FamotidineDrug
Administered orally in tablet form
MidazolamDrug
Administered orally in syrup form
DigoxinDrug
Administered orally in tablet form
RosuvastatinDrug
Administered orally in tablet form
QuinidineDrug
Administered orally in tablet form
NX-5948Drug
Also called Bexobrutideg
Administered in capsule form
| Study group | Role | What they receive |
|---|---|---|
| NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo | Experimental | Not described Receives: Drug: NX-5948; Drug: Placebo |
| NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions | Experimental | Not described Receives: Drug: NX-5948; Drug: Esomeprazole |
| NX-5948 with and without famotidine under fasting and fed conditions | Experimental | Not described Receives: Drug: Famotidine; Drug: NX-5948 |
| Midazolam with and without NX-5948 | Experimental | Not described Receives: Drug: Midazolam; Drug: NX-5948 |
| Digoxin with and without NX-5948 | Experimental | Not described Receives: Drug: Digoxin; Drug: NX-5948 |
| Rosuvastatin with and without NX-5948 | Experimental | Not described Receives: Drug: Rosuvastatin; Drug: NX-5948 |
| NX-5948 with and without quinidine | Experimental | Not described Receives: Drug: Quinidine; Drug: NX-5948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Measured: 9 weeks
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf): NX-5948
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Measured: 9 weeks
Maximum observed concentration (Cmax): NX-5948
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Measured: 9 weeks
AUC0-t: Midazolam, rosuvastatin, or digoxin
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Measured: 9 weeks
AUC0-inf: Midazolam, rosuvastatin, or digoxin
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Measured: 9 weeks
Cmax: Midazolam, rosuvastatin, or digoxin
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Measured: 9 weeks
Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram
Measured: Baseline, 9 weeks
Number of participants with treatment-emergent adverse events
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start30 Nov 2024
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nurix Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717269
- Sponsor's protocol ID
- NX-5948-304
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules
- ClinicalTrials.gov ID
- NCT06717269
- Acronym / sponsor ID
- NX-5948-304
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Nurix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 4 Dec 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 multiple part, multiple cohort study evaluating single and multiple ascending doses, relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo | Experimental | Drug: NX-5948, Drug: Placebo |
| NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions | Experimental | Drug: NX-5948, Drug: Esomeprazole |
| NX-5948 with and without famotidine under fasting and fed conditions | Experimental | Drug: Famotidine, Drug: NX-5948 |
| Midazolam with and without NX-5948 | Experimental | Drug: Midazolam, Drug: NX-5948 |
| Digoxin with and without NX-5948 | Experimental | Drug: Digoxin, Drug: NX-5948 |
| Rosuvastatin with and without NX-5948 | Experimental | Drug: Rosuvastatin, Drug: NX-5948 |
| NX-5948 with and without quinidine | Experimental | Drug: Quinidine, Drug: NX-5948 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, adult, male or female 19-55 years of age
- Continuous non-smoker who has not used nicotine and tobacco-containing products for at least 3 months prior to the first dosing
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, or vital signs at the screening visit, as deemed by the Principal Investigator (PI) or designee
- Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
Key exclusion criteria (20 listed)
- Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
- History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948
- History or presence of alcohol or drug abuse within the past 2 years
- History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds
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 |
|---|---|---|
| NX-5948Also: BexobrutidegAdministered orally in tablet or capsule form | Drug | NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo, NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions |
| EsomeprazoleAdministered orally in capsule form | Drug | NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions |
| PlaceboAdministered orally matching NX-5948 tablets | Drug | NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo |
| FamotidineAdministered orally in tablet form | Drug | NX-5948 with and without famotidine under fasting and fed conditions |
| MidazolamAdministered orally in syrup form | Drug | Midazolam with and without NX-5948 |
| DigoxinAdministered orally in tablet form | Drug | Digoxin with and without NX-5948 |
| RosuvastatinAdministered orally in tablet form | Drug | Rosuvastatin with and without NX-5948 |
| QuinidineAdministered orally in tablet form | Drug | NX-5948 with and without quinidine |
| NX-5948Also: BexobrutidegAdministered in capsule form | Drug | Digoxin with and without NX-5948, Midazolam with and without NX-5948, NX-5948 with and without famotidine under fasting and fed conditions, NX-5948 with and without quinidine, Rosuvastatin with and without NX-5948 |
Primary outcome
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948
Time frame: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf): NX-5948
Time frame: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Maximum observed concentration (Cmax): NX-5948
Time frame: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
AUC0-t: Midazolam, rosuvastatin, or digoxin
Time frame: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
AUC0-inf: Midazolam, rosuvastatin, or digoxin
Time frame: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Cmax: Midazolam, rosuvastatin, or digoxin
Time frame: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram
Time frame: Baseline, 9 weeks
Number of participants with treatment-emergent adverse events
Time frame: Up to 10 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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Nurix Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NX-5948, Esomeprazole and Famotidine in people with Healthy Volunteer, run by Nurix Therapeutics, Inc. at 2 sites 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 5 inclusion and 20 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948 (time frame: 9 weeks). The study lists 8 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 28 Jul 2026.