Not Yet Recruiting
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females - CN012-0067
Aggiornato:
21 novembre, 2025
|
ClinicalTrials.gov.
Fase
Sesso
Fascia d'età
Sede/i
Not Yet Recruiting
Inclusion Criteria: - Participants should have a body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. - Participants should have well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study. - Participants should be willing to exclusively pump breast milk throughout the treatment period and during the 24-hour post last dose period of milk collection during the CRU domincile period. - Participants should agree not to breastfeed or provide milk to infant until after 96 hours post last dose. Exclusion Criteria: - Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges as assessed by the investigator. - Participants must not have history or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (eg, obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. - Other protocol defined inclusion/exclusion criteria apply.
Ti consigliamo vivamente di contattare BMS per segnalare gli effetti collaterali (eventi avversi)
Qui vengono definiti gli effetti collaterali (eventi avversi) e altri eventi da segnalare
Segnala effetti collaterali (eventi avversi) o reclami sulla qualità del prodotto: informazioni mediche