TAK-555-4006: A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® (prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data from the Nursing Infant

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Pharmacokinetic study

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Pharmacokinetic study

Study drug and medical condition

• Medicinal product name, other:
  MOTEGRITY
• Study drug International non-proprietary name (INN) or common name:
  PRUCALOPRIDE SUCCINATE
• Anatomical Therapeutic Chemical (ATC) code:
  (A06AX05) prucalopride

  prucalopride
• Medical condition to be studied:
  Constipation

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  12

Study design details

• Main study objective:
  The main objective of the study is to measure prucalopride concentrations in breast milk.
• Outcomes:
  1. Dose-Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm]). AUC [milk, norm] will be normalized to 2-milligrams (mg) daily maternal dose.; 2. Dose-Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm]). C [ave, milk, norm] will be normalized to 2-mg daily maternal dose.; 3. Time Interval Over Which the AUC [milk, norm] Measured; 4. Dose-Normalized Daily Infant Dosage (DID [norm]). DID [norm] will be normalized to 2-mg daily maternal dose.; 5. Percentage of Relative Infant Dose (RID [%]) ; 6. Number of Infants With Adverse Events (AEs) Based on Maternal Report; 7. Change in Growth (Length, Weight, Head Circumference) During the First Year of Life in Infants; 8. Infant’s Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)
• Data analysis plan:
  Primary outcomes, i.e. pharmacokinetic parameters, will be determined from the breast milk concentration-time data for prucalopride by noncompartmental analysis using actual sampling times. ; Summary statistics will be determined for all PK parameters. ; The secondary endpoints of the study are maternal report of infant AEs, growth and performance on development questionnaires. ; All secondary endpoints will be summarized using descriptive statistics. ; Means and standard deviations (SDs) will be presented for continuous variables and frequencies and percentages will be presented for categorical variables. Associations between drug levels and infant outcomes will be explored.