A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers
- Summary
- 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.
- Short title
- A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers
- Official 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-05-01
- First posted
- 2024-12-04
- Registry last updated
- 2026-07-28
- Primary completion date
- 2026-05-01
- Start date
- 2024-11-30
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Nurix Therapeutics, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06717269
- ClinicalTrials.gov ID
- NCT06717269
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948
Timeframe: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf): NX-5948
Timeframe: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Maximum observed concentration (Cmax): NX-5948
Timeframe: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
AUC0-t: Midazolam, rosuvastatin, or digoxin
Timeframe: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
AUC0-inf: Midazolam, rosuvastatin, or digoxin
Timeframe: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Cmax: Midazolam, rosuvastatin, or digoxin
Timeframe: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram
Timeframe: Baseline, 9 weeks
Number of participants with treatment-emergent adverse events
Timeframe: Up to 10 weeks
- Sex
- All
- Age groups
- Adults
- Minimum age
- 19 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
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.
- CelerionPhoenix, United States
- CelerionLincoln, United States