Healthy VolunteerPhase 1NCT06691828
Absolute Bioavailability, Absorption, Metabolism, Excretion, and Mass Balance Study of [14C] NX-5948
A Phase 1 study testing NX-5948 in people with Healthy Volunteer, run by Nurix Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, 2-period, open-label, single-dose, fixed-sequence study to assess the absolute bioavailability, absorption, metabolism, excretion, and mass balance of [14C]-NX-5948. Period 1 will analyze PD (pharmacodynamics) and exploratory biomarkers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- NX-5948
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 5 Dec 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 19 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:
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- 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 alcohol or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds.
Show all 22Show fewer
- History or presence of:
- 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.
- Any significant (as determined by the PI) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies.
- Has tattoo(s) or scarring at or near the site of IV injection or any other condition which may interfere with IV injection site examination, in the opinion of the PI or designee.
- Previous exposure to NX-5948.
- Any significant acute illness within 30 days prior to first dosing.
- Regular alcohol consumption > 14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) prior to first dosing.
- Positive urine drug or alcohol results at the screening visit or first check in.
- 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.
- Has received radiolabeled substances or has been exposed to radiation sources over the past 12 months or is likely to receive radiation exposure or radioisotopes within the next 12 months such that participation in this study would increase their total exposure beyond the recommended levels considered safe (i.e., weighted annual limit recommended by the FDA 21CFR361 of 5000 mrem).
- 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, Open-Label, 2-Period, Fixed-Sequence Study to Assess the Absolute Bioavailability, Absorption, Metabolism, Excretion, and Mass Balance of [14C]-NX-5948 in Healthy Males
This is a Phase 1, 2-period, open-label, single-dose, fixed-sequence study to assess the absolute bioavailability, absorption, metabolism, excretion, and mass balance of [14C]-NX-5948. Period 1 will analyze PD (pharmacodynamics) and exploratory biomarkers. Period 2 will analyze total radioactivity and metabolite profiling.
Read the detailed description
In Period 1 all subjects will receive a single dose of NX-5948 by IV and undergo pre and post dose labs to assess PK (pharmacokinetics) and PD parameters.
In Period 2 all subjects will receive a single dose of NX-5948 by mouth. Pre and post dose blood, urine, and feces will be collected until NX-5948 is no longer identified in samples.
Periods 1 and 2: Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
- Conditions
- Healthy Volunteer
- Being tested
- NX-5948
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-5948Drug
NX-5948 will be given once by IV and then given once by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Arm IV and Oral | Experimental | This single Arm will include a single dose by IV and a single dose given by mouth for all 8 subjects. Receives: Drug: NX-5948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Area Under the Curve (AUC0-inf), Half-life (T1/2) after IV dosing of NX-5948
Characterize the Area Under the Curve (AUC0-inf), Half-life (T1/2) of a single IV dose of NX-5948 in healthy adult male subjects.
Measured: 9 weeks
Evaluation of metabolite after oral dosing with [14C]-NX-5948
Identify major metabolite and its AUC in plasma following a single oral dose of [14C]-NX-5948 in healthy adult male subjects.
Measured: 9 weeks
Assessment of bioavailability with oral dosing of NX-5948
Determine the absolute bioavailability (ABA) of an oral formulation of [NX-5948C]- in healthy adult male subjects.
Measured: 9 weeks
Assessment of total radioactivity after oral dosing with NX-5948
Determine the recovery of total radioactivity (TRA; mass balance) as a percentage of the administered dose after a single oral dose of [14C]-NX-5948 in healthy adult male subjects.
Measured: 9 weeks
Assessment of whole blood to plasma ratio for TRA after oral dosing with NX-5948
Characterize whole blood to plasma ratio for TRA following a single oral dose of [14C]-NX-5948 in healthy adult male subjects (i.e., whole blood:plasma partitioning ratio).
Measured: 9 weeks
Characterize the Clearance (CL) after IV dosing of NX-5948
Character the Clearance (CL) after IV dosing of NX-5948in healthy adults male subjects.
Measured: 9 weeks
Characterize the Volume of distribution (Vz) after IV dosing of NX-5948
Character the Volume of distribution (Vz) after IV dosing of NX-5948in healthy adults male subjects.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Nov 2024
- Primary completion28 Nov 2024
- Study completion5 Dec 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT06691828
- Sponsor's protocol ID
- NX-5948-303
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2024
- Last updated
- 12 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 2-Period, Fixed-Sequence Study to Assess the Absolute Bioavailability, Absorption, Metabolism, Excretion, and Mass Balance of [14C]-NX-5948 in Healthy Males
- ClinicalTrials.gov ID
- NCT06691828
- Acronym / sponsor ID
- NX-5948-303
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nurix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 15 Nov 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-period, open-label, single-dose, fixed-sequence study to assess the absolute bioavailability, absorption, metabolism, excretion, and mass balance of [14C]-NX-5948. Period 1 will analyze PD (pharmacodynamics) and exploratory biomarkers. Period 2 will analyze total radioactivity and metabolite profiling.
Detailed description
In Period 1 all subjects will receive a single dose of NX-5948 by IV and undergo pre and post dose labs to assess PK (pharmacokinetics) and PD parameters.
In Period 2 all subjects will receive a single dose of NX-5948 by mouth. Pre and post dose blood, urine, and feces will be collected until NX-5948 is no longer identified in samples.
Periods 1 and 2: Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm IV and Oral | Experimental | Drug: NX-5948This single Arm will include a single dose by IV and a single dose given by mouth for all 8 subjects. |
Who may qualify
- Ages
- 19 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 (22 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- 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 alcohol or drug abuse within the past 2 years prior to the first dosing.
- 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-5948NX-5948 will be given once by IV and then given once by mouth. | Drug | Active Treatment Arm IV and Oral |
Primary outcome
Characterize Area Under the Curve (AUC0-inf), Half-life (T1/2) after IV dosing of NX-5948
Time frame: 9 weeks
Characterize the Area Under the Curve (AUC0-inf), Half-life (T1/2) of a single IV dose of NX-5948 in healthy adult male subjects.
Evaluation of metabolite after oral dosing with [14C]-NX-5948
Time frame: 9 weeks
Identify major metabolite and its AUC in plasma following a single oral dose of [14C]-NX-5948 in healthy adult male subjects.
Assessment of bioavailability with oral dosing of NX-5948
Time frame: 9 weeks
Determine the absolute bioavailability (ABA) of an oral formulation of [NX-5948C]- in healthy adult male subjects.
Assessment of total radioactivity after oral dosing with NX-5948
Time frame: 9 weeks
Determine the recovery of total radioactivity (TRA; mass balance) as a percentage of the administered dose after a single oral dose of [14C]-NX-5948 in healthy adult male subjects.
Assessment of whole blood to plasma ratio for TRA after oral dosing with NX-5948
Time frame: 9 weeks
Characterize whole blood to plasma ratio for TRA following a single oral dose of [14C]-NX-5948 in healthy adult male subjects (i.e., whole blood:plasma partitioning ratio).
Characterize the Clearance (CL) after IV dosing of NX-5948
Time frame: 9 weeks
Character the Clearance (CL) after IV dosing of NX-5948in healthy adults male subjects.
Characterize the Volume of distribution (Vz) after IV dosing of NX-5948
Time frame: 9 weeks
Character the Volume of distribution (Vz) after IV dosing of NX-5948in healthy adults male subjects.
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 12 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 NX-5948 in people with Healthy Volunteer, 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 22 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 12 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?
Characterize Area Under the Curve (AUC0-inf), Half-life (T1/2) after IV dosing of NX-5948 (time frame: 9 weeks). The study lists 7 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 12 Mar 2025.