A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers

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

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.

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.