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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
223
Administered orally in tablet or capsule form
Administered orally in capsule form
Administered orally matching NX-5948 tablets
Celerion
Phoenix, Arizona, United States
Celerion
Lincoln, Nebraska, United States
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Time frame: 9 weeks
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf): NX-5948
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Time frame: 9 weeks
Maximum observed concentration (Cmax): NX-5948
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
Time frame: 9 weeks
AUC0-t: Midazolam, rosuvastatin, or digoxin
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Time frame: 9 weeks
AUC0-inf: Midazolam, rosuvastatin, or digoxin
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Time frame: 9 weeks
Cmax: Midazolam, rosuvastatin, or digoxin
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
Time frame: 9 weeks
Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram
Time frame: Baseline, 9 weeks
Number of participants with treatment-emergent adverse events
Time frame: Up to 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered orally in tablet form
Administered orally in syrup form
Administered orally in tablet form
Administered orally in tablet form
Administered orally in tablet form
Administered in capsule form