Healthy Volunteers
Conditions
Keywords
Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, Healthy lactating women
Brief summary
The purpose of this study is to characterize the PK of xanomeline and trospium in breast milk and plasma in healthy lactating female participants, following multiple oral administration of KarXT in healthy lactating participants.
Interventions
Specified dose on specified days
Sponsors
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed concentration (Cmax) of KarXT in Milk | Up to Day 7 | — |
| Time of maximum observed concentration (Tmax) of KarXT in Milk | Up to Day 7 | — |
| Area under the concentration-time curve from time zero to 12 hours post morning dose [AUC(0-12)] of KarXT in Milk | Up to Day 7 | — |
| Area under the concentration-time curve from time zero to 24 hours post morning dose [AUC(0-24)] of KarXT in Milk | Up to Day 7 | — |
| Average concentration (Cavg) of KarXT in Milk | Up to Day 7 | — |
| Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)] | Up to Day 7 | — |
| Total amount of KarXT recovered in milk (AR) | Up to Day 7 | — |
| Milk-plasma ratio of KarXT (M/P) | Up to Day 7 | Calculated as milk AUC(0-12)/plasma AUC(0-12) |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of KarXT in plasma | Up to Day 7 |
| Tmax of KarXT in plasma | Up to Day 7 |
| AUC (0-12) of KarXT in plasma | Up to Day 7 |
| AUC (0-24) of KarXT in plasma | Up to Day 7 |
| Cavg of KarXT in plasma | Up to Day 7 |
| Estimated daily infant dosage of KarXT | Up to Day 7 |
| Relative infant dosage of KarXT | Up to Day 7 |
| Number of participants with Adverse Events (AEs) | Up to Day 34 |
| Number of participants with Serious Adverse Events (SAEs) | Up to Day 34 |
| Number of participants with physical examination abnormalities | Up to Day 7 |
| Number of participants with vital signs abnormalities | Up to Day 7 |
| Number of participants with 12-Lead electrocardiogram (ECG) abnormalities | Up to Day 7 |
| Number of participants with clinical laboratory abnormalities | Up to Day 7 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 7 |
| Number of participants with Adverse Events of Special Interest (AESIs) | Up to Day 34 |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed