Comparing the absorption of NX-5948 tablets and capsules

A Phase 1, Open-Label Study in Healthy Volunteers to Evaluate the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, and the Effect of Food and an Acid-reducing Agent on the Pharmacokinetics of NX-5948

This study tests how well healthy volunteers absorb NX-5948 in tablet form compared to capsules, both when they have eaten and when they haven't.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Nurix Therapeutics, Inc. (industry)
• Locations: 1 site (Lincoln, Nebraska)
• Trial ID: NCT06717269 on ClinicalTrials.gov

What this trial studies

This study evaluates how well NX-5948 tablets are absorbed compared to capsules in healthy volunteers. It consists of two cohorts, where participants will receive NX-5948 in both tablet and capsule forms under different conditions, including fasting and fed states. Additionally, the study will assess the impact of food and an acid-reducing agent on the drug's pharmacokinetics. Blood samples will be collected to analyze the drug's absorption and effects.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 19-55 who meet specific health criteria.

Not a fit: Patients with significant medical histories or conditions that could affect drug absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could optimize the formulation of NX-5948 for better patient outcomes.

How similar studies have performed: Previous studies have shown varying success in evaluating drug formulations, but this specific approach is relatively novel.

Eligibility 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, vital signs, or 12-lead safety ECGs at the screening visit, 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.

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.

Where this trial is running

Lincoln, Nebraska

• Celerion — Lincoln, Nebraska, United States (RECRUITING)

Study contacts

• Study coordinator: Angie Badgett, MBA

Conditions: Healthy Volunteer