Celerion | Lincoln Celerion CPU
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About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
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Central trial contact
Allen Hunt, MD; Angie Badgett, MBA
Data sourced from clinicaltrials.gov
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