The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
Oral monlunabant
Oral placebo (monlunabant)
Altasciences Clinical LA, Inc.
Cypress, California, United States
Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
Number of events
Time frame: From dosing (day 1) to end of study visit (day 21)
AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant
h\*nmol/L
Time frame: From pre-dose (day 1) to end of study visit (day 21)
Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant
nmol/L
Time frame: From pre-dose (day 1) to end of study visit (day 21)
tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant
h (hours)
Time frame: From pre-dose (day 1) to end of study visit (day 21)
t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant
h (hours)
Time frame: From pre-dose (day 1) to end of study visit (day 21)
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