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This is a multiple part, multiple cohort study evaluating the relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NX-5948 tablet and capsule under fasted and fed conditions | Experimental |
| |
| NX-5948 tablet and capsule combined with esomeprazole under fasted conditions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NX-5948 | Drug | Administered orally in tablet or capsule form |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameters: NX-5948 tablets versus capsules | Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (AUC) | 9 weeks |
| Assessment of PK parameters: NX-5948 tablets versus capsules | Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Cmax) | 9 weeks |
| Assessment of PK parameters NX-5948 tablets versus capsules | Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Tmax) | 9 weeks |
| Food effect and effect of esomeprazole on AUC0-t for single-dose NX-5948 tablet | Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet | 9 weeks |
| Food effect and effect of esomeprazole on AUC0-inf for single-dose NX-5948 tablet | Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet | 9 weeks |
| Food effect and effect of esomeprazole on Cmax for single-dose NX-5948 tablet | Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet | 9 weeks |
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Key Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angie Badgett, MBA | Contact | 402-437-6351 | angie.badgett@celerion.com | |
| Allen Hunt, MD | Contact | 402-437-6351 | allen.hunt@celerion.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nurix Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Recruiting | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole | Drug | Administered orally in capsule form |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |