Pharmacokinetics of Zelquistinel in Fasted or Fed State (NCT07099989) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pharmacokinetics of Zelquistinel in Fasted or Fed State
United States32 participantsStarted 2025-07-24
Plain-language summary
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption of a single dose of Zelquistinel 3 mg or 10 mg oral tablets tablets in healthy adult volunteers.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion Criteria:
* Available for the entire study period; willing and able to comply with the protocol requirements and study restrictions, to remain at the CRU for the required duration of the study, and to return for the Follow-Up Visit
* Male or female participants ≥18 to ≤59 years of age at Screening
* Minimum body weight of at least 50.0 kg at Screening
* Body mass index (BMI) 18.0 to 35.0 kg/m2, inclusive, at Screening
* Able and willing to swallow whole tablets without breaking, cutting, or chewing
* Non- or ex-smokers
* Considered generally healthy in the opinion of an investigator upon completion of medical history, physical examination, vital sign measurements, Screening clinical laboratory test results, and Screening ECG
* Female participants of childbearing potential must use an acceptable method of contraception, including hormonal contraceptives, abstinence from heterosexual intercourse, intrauterine device with or without hormones, or double-barrier method (eg, condom and spermicide) for 30 days before Screening, during the study, and for 30 days after the last administration of study drug
* Female participants of nonchildbearing potential should be surgically sterile (ie, have undergone complete hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses)
* Male participants must agree to use a double-barrier method (condom and spermicide) or remain abstinent from hete…
What they're measuring
1
Pharmacokinetic parameter Maximum Concentration (Cmax) in plasma
Timeframe: Hour zero to Hour 24
2
Pharmacokinetic parameter Area Under the Curve (AUC) for Concentration in plasma over time
Timeframe: Hour 0 to hour 24
3
Pharmacokinetic parameter Maximum Concentration (Cmax) in cerebrospinal fluid
Timeframe: Hour 0 to Hour 24
4
Pharmacokinetic parameter Area Under the Curve (AUC) for concentration in cerebrospinal fluid over time