Pharmacokinetics of Zelquistinel in Fasted or Fed State

This is a randomized, open-label, single-dose, 2-cohort, 2-period crossover study to assess the effect of food on the pharmacokinetics, safety, and tolerability of zelquistinel tablet in healthy adult participants. Two dose levels, 3 and 10 mg, will each be evaluated for food effect, 1 dose level per cohort, with approximately 32 participants (16 per cohort).

* Cohort 1: zelquistinel, 3 mg single oral tablet administered under fasted and fed conditions * Cohort 2: zelquistinel, 10 mg single oral tablet administered under fasted and fed conditions

Study Design: This is a randomized, open-label, single-dose, 2-cohort, 2-period crossover study to assess the effect of food on the pharmacokinetics, safety, and tolerability of GATE-251 tablet in healthy adult participants. Two dose levels, 3 and 10 mg, will each be evaluated for food effect, 1 dose level per cohort, with approximately 32 participants (16 per cohort).

* Cohort 1: zelquistinel, 3 mg single oral tablet administered under fasted and fed conditions * Cohort 2: zelquistinel, 10 mg single oral tablet administered under fasted and fed conditions After meeting eligibility requirements, participants will be admitted to the clinical research unit on Day -1. Participants within each cohort will be randomly assigned in a 1:1 ratio to a treatment sequence. Cohorts will be enrolled sequentially. Participants will only participate in 1 cohort.

On Day 1 of each period, participants will receive one of the following treatments:

* Treatment A (reference): zelquistinel, 3 mg tablet, fasted conditions * Treatment B (test): GATE-251, 3 mg tablet, fed conditions (high-fat, high-calorie meal) * Treatment C (reference): zelquistinel, 10 mg tablet, fasted conditions * Treatment D (test): zelquistinel, 10 mg tablet, fed conditions (high-fat, high-calorie meal) Fasted and fed conditions and test meal composition are defined by FDA guidance. For the fasted condition, zelquistinel will be administered after an overnight fast of at least 10 hours.

For the fed condition, after an overnight fast of at least 10 hours, participants will start the test meal approximately 30 minutes before administration of zelquistinel. The test meal will be entirely consumed within 30 minutes.

For both fasted and fed conditions, zelquistinel will be administered with approximately 240 mL of water. Up to 200 mL of additional water will be allowed in increments of 50 mL, as needed. No water will be allowed for at least 1 hour before or after zelquistinel administration, except for the water consumed during administration. No food will be allowed for at least 4 hours after zelquistinel administration. In addition, participants will be semi-recumbent during the test meal and for at least 4 hours after study drug administration, except for when procedures or adverse events require the supine position.