Relative Bioavailability of NX-5948 Tablets Vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets
Purpose
This is a 2-cohort, fixed-sequence, 3-period, relative bioavailability, food-effect, and drug-drug interaction study. It is an open-label study evaluating the relative bioavailability of NX-5948 tablets compared to capsules, and the effect of food and an acid-reducing agent on the pharmacokinetics (PK) of NX-5948.
Condition
- Healthy Volunteer
Eligibility
- Eligible Ages
- Between 19 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a 2-cohort, fixed-sequence, 3-period, relative bioavailability, food-effect, and drug-drug interaction study, which will enroll 18 volunteers. A total of 48 healthy, adult male and female (of non-childbearing potential) volunteers are planned to be enrolled.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NX-5948 tablet and capsule under fasted and fed conditions |
Cohort 1: Single dose of NX-5948 tablet under fasted and fed conditions. Also, single dose of NX-5948 capsule under fasted conditions. |
|
|
Experimental NX-5948 tablet combined with esomeprazole under fasted conditions |
Cohort 2: Single dose of NX-5948 tablet combined with esomeprazole under fasted conditions. Also, a single dose of NX-5948 capsule under fasted conditions. |
|
Recruiting Locations
Celerion
Lincoln, Nebraska 68502
Lincoln, Nebraska 68502
More Details
- NCT ID
- NCT06717269
- Status
- Recruiting
- Sponsor
- Nurix Therapeutics, Inc.
Detailed Description
In Cohort 1, Period 1 volunteers will receive NX-5948 in a tablet form under fasting conditions. In Period 2, volunteers will receive NX-5948 in a capsule form under fasting conditions. In Period 3, volunteers will receive NX-5948 in a tablet form under fed conditions. In Cohort 2, Period 1 volunteers will receive NX-5948 in a capsule form under fasting conditions. In Period 2, volunteers will receive NX-5948 in a tablet form under fasting conditions. In Period 3, esomeprazole will be administered once daily for 5 consecutive days with a single dose of NX-5948 tablet coadministered on Day 5. In both cohorts, serial blood samples will be collected to assess PK.