FindTrial
Sign In

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 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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06717269
Enrollment
223
Registered
2024-12-04
Start date
2024-11-30
Completion date
2026-05-01
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief 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.

Interventions

DRUGNX-5948

Administered orally in tablet or capsule form

DRUGEsomeprazole

Administered orally in capsule form

DRUGPlacebo

Administered orally matching NX-5948 tablets

DRUGFamotidine

Administered orally in tablet form

DRUGMidazolam

Administered orally in syrup form

DRUGDigoxin

Administered orally in tablet form

DRUGRosuvastatin

Administered orally in tablet form

DRUGQuinidine

Administered orally in tablet form

Sponsors

Nurix Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Key Inclusion Criteria: * 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

* 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: * 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/

Design outcomes

Primary

MeasureTime frameDescription
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-59489 weeksNX-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-59489 weeksNX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Maximum observed concentration (Cmax): NX-59489 weeksNX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
AUC0-t: Midazolam, rosuvastatin, or digoxin9 weeksMidazolam, rosuvastatin, or digoxin administered with and without NX-5948
AUC0-inf: Midazolam, rosuvastatin, or digoxin9 weeksMidazolam, rosuvastatin, or digoxin administered with and without NX-5948
Cmax: Midazolam, rosuvastatin, or digoxin9 weeksMidazolam, rosuvastatin, or digoxin administered with and without NX-5948
Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogramBaseline, 9 weeks—
Number of participants with treatment-emergent adverse eventsUp to 10 weeks—

Countries

United States

Contacts

STUDY_DIRECTORStudy Director

Nurix Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026