Suppression of Lactation after Delivery in Postpartum Women
Conditions
Interventions
Product Code: XOMA 213
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: XOMA 213
Current Sponsor code: XOMA 213
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equ
Sponsors
XOMA (US) LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included in the study if ALL of the following criteria are met: 1. Provide written informed consent before any study specific procedures are performed 2. Female, aged 18 to 45 years, pregnant with a gestational age of at least 36 weeks, and expected to deliver within 21 days of study Screening 3. Wishing to suppress lactation immediately after delivery 4. Willing to be hospitalized for 3 consecutive days immediately after delivery 5. For female subjects with reproductive potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile), a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for at least 3 months after administration of study drug. For women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if ANY of the following criteria are met: 1. History of mastitis 2. History of pituitary disease 3. History of intrauterine fetal death, bleeding disorder, pre-eclampsia, liver or kidney impairment, or any severe complication associated with the current or prior pregnancies 4. History of pregnancy-related hypertension, (eg, preeclampsia, eclampsia, or post partum hypertension), which are contraindications to cabergoline 5. Major general surgery (including C-section) within 3 months before study entry or anticipated during the study period 6. Seropositivity for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody 7. Treatment within 30 days before study entry or concurrent treatment during the study with any drug, other than study drug, that affects prolactin levels or lactation (eg, cabergoline, bromocriptine, other dopamine agonists, or antidepressants) 8. History of severe allergic or anaphylactic reaction to monoclonal antibodies 9. Any out-of-range laboratory value at Screening that has not been reviewed, approved, and documented as not clinically significant by the Investigator 10. Presence of clinically significant cardiac disease or failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension 11. History of malignancy within 3 years before study entry other than carcinoma in situ of the cervix or adequately treated nonmetastatic squamous or basal cell carcinoma of the skin 12. Known allergy or sensitivity to XOMA 213 or any component of the study drug or known contraindications to treatment with cabergoline 13. Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug, whichever is longer, before Day 1. Participation in registries and purely diagnostic studies is allowed. 14. Any condition that, in the opinion of the investigator, would jeopardize the subject’s safety after exposure to the study drug. Any condition (eg, psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To evaluate the safety, tolerability, and pharmacokinetics of a single intravenous dose of XOMA 213 administered postpartum in women who wish to suppress lactation immediately postpartum. ? To evaluate the pharmacodynamics of XOMA 213 as measured by changes in milk secretion, breast engorgement, pain and tenderness, and rebound symptomology.;Secondary Objective: Not applicable;Primary end point(s): Biological: ? Assessment of change from baseline milk secretion, breast engorgement, and pain and tenderness at Days 1, 2, 3, 5, 8, and 21 post-dose. ? Concomitant medications (such as analgesics) and other non-medication treatment measures (such as ice compresses) for relief of pain Safety: ? Safety will be assessed through an examination of the incidence, severity, and type of treatment-emergent adverse events and changes from baseline vital signs, physical examination results, lab values, ECG results, and infusion site reactions. Pharmacokinetics: ? Blood samples will be collected after dosing to determine concentration of XOMA 213 in serum. The following noncompartmental PK parameters will be calculated: Cmax, Tmax, CEOI, t1/2, AUC0-t, AUC0-inf, CL, Vz, and VSS.;Timepoint(s) of evaluation of this end point: Days 1, 2, 3, 5, 8, and 21 post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactRegulatory Affairs
León Research S.L
Outcome results
None listed