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Completed

NCT Number: NCT06717269

A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/Exclusion criteria may apply as defined in the protocol.

Treatment and study plan

NX-5948

Drug

Administered orally in tablet or capsule form

Other names: Bexobrutideg

Esomeprazole

Drug

Administered orally in capsule form

Placebo

Drug

Administered orally matching NX-5948 tablets

Famotidine

Drug

Administered orally in tablet form

midazolam

Drug

Administered orally in syrup form

Digoxin

Drug

Administered orally in tablet form

Rosuvastatin

Drug

Administered orally in tablet form

Quinidine

Drug

Administered orally in tablet form

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. AUC0-t: Midazolam, rosuvastatin, or digoxin

    Time frame: 9 weeks

    Midazolam, rosuvastatin, or digoxin administered with and without NX-5948

  5. AUC0-inf: Midazolam, rosuvastatin, or digoxin

    Time frame: 9 weeks

    Midazolam, rosuvastatin, or digoxin administered with and without NX-5948

  6. Cmax: Midazolam, rosuvastatin, or digoxin

    Time frame: 9 weeks

    Midazolam, rosuvastatin, or digoxin administered with and without NX-5948

  7. Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram

    Time frame: Baseline, 9 weeks

  8. Number of participants with treatment-emergent adverse events

    Time frame: Up to 10 weeks

Sponsors and collaborators

Lead sponsor

Nurix Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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