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Not Yet Recruiting

KarXT Concentrations in the Breast Milk and Plasma of Lactating Females - CN012-0067

Aktualisiert: 21 November, 2025   |   ClinicalTrials.gov

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Studiendetails

  • Phase 4

    Phase

  • Geschlecht(er)

  • 18+

    Altersgruppe

  • 1

    Standort(e)

  • Not Yet Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: KarXT
Drug: Xanomeline/trospium chloride

Wichtigste Eignungskriterien

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.

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