Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the relative bioavailability, and the rate and
      extent of absorption of bromocriptine in male and female children and adolescent Type 2
      Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions.

      It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes
      children aged 10- to less than 18 years differs appreciably from that in healthy adults.
      Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children
      have demonstrated little difference in clearance among children over 10 years of age compared
      to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may
      impart differences that could affect the pharmacokinetic properties of bromocriptine-QR.
      Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18
      years who have type 2 diabetes. After describing the profile of bromocriptine-quick release
      in this patient population, a follow on study will be conducted to evaluate its safety and
      efficacy in treating children and adolescents who have type 2 diabetes.

      The pharmacokinetic profile of bromocriptine will be determined following the administration
      of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study
      will be a single period, bioavailability study in 30 patients. The study duration will be 3
      days.
    

Detailed description: 
      The study is a multi-center, single dose, open-label, 1-period design. Thirty (30) patients
      will be enrolled in the study and at least twenty-four (24) patients are expected to complete
      the study.

      Male and female patients with confirmed Type 2 Diabetes, non-or ex-smokers, aged 10 to less
      than 18 years will be selected according to the inclusion and exclusion criteria.

      Patients will be admitted to the clinical site at least 10 hours prior to drug administration
      which will occur within 2 hours of waking on the morning of Day 2.

      Ondansetron hydrochloride will be administered orally, approximately 6 hours before the
      dosing time of Cycloset (bromocriptine mesylate). Subjects weighing 50 to 60 kg will receive
      6mg ondansetron hydrochloride (liquid 7.5 ml) and subjects weighing ≥60 kg will receive
      ondansetron hydrochloride 8 mg (liquid 10 ml).

      A single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate), of approximately 0.048
      mg/kg, will be administered orally with 240 mL of water in the morning, after a 10-hour
      overnight fast, and thirty minutes after the start of a standardized breakfast that meets
      American Diabetes Association diet recommendations.

      On day 2, after a supervised overnight fast, the patients will be awakened, vital signs
      (blood pressure, pulse rate and body temperature) will be measured and the first blood sample
      (T= 0) will be collected.

      Seventeen (17) blood samples will be collected for pharmacokinetic sampling at 0.25, 0.50,
      0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 and 36 hours post drug administration.

      Finger sticks for blood glucose levels will be obtained every hour for the first 4 hours
      following administration of bromocriptine mesylate, and then additionally as deemed necessary
      by the study physician.

      Safety will be evaluated through the assessment of adverse events and laboratory tests and
      vital signs.
    

Intervention name(s): Bromocriptine mesylate
Intervention type(s): Drug
Intervention description(s): Cycloset (bromocriptine mesylate quick release) 0.8 mg tablets, weight adjusted 1.6 mg- 4.8 mg
Other intervention name(s): Cycloset; Bromocriptine-QR; BQR
Intervention MeSH terms: Bromocriptine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Children; Adolescents; Bioavailability; Cycloset; Bromocriptine Mesylate