Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects

Completed · Phase 1

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID: NCT02078440
Run by: VeroScience
People needed: 18
Starts: 2014-01-01
Expected to finish: 2016-06-01
Last updated by the study team: 2016-08-29

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Availability for entire study and willingness to adhere to protocol requirements as evidenced by (ICF) duly read, signed and dated by the patient and responsible parent or guardian
Positive diagnosis of T2DM according to ADA criteria. There is no requirement for time since diagnosis as long as ADA guidelines have been followed.
Aged at least 10 years but less than 18 years at time of enrollment
BMI greater than 80th percentile for age and sex and body weight equal to or greater than 50 kg
Clinical laboratory values within the laboratory's stated normal range - if not within this range, they must be without any clinical significance
Healthy according to the medical history, laboratory results and physical examination
Non- or ex-smokers (defined as someone who completely stopped smoking for at least 30 days before day 1 of this study).

You may not qualify if…

Evidence to indicate a diagnosis of Type 1 diabetes
Body weight less than 50 kilograms
Systolic blood pressure lower than 115mmHg or diastolic blood pressure lower than 68 mmHg
Significant history of hypersensitivity to bromocriptine mesylate, ondansetron, other ergot alkaloids or any related products, including excipients of the formulation as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Serum aspartate aminotransferase (AST) greater than 3X ULN, and/or serum alanine aminotransferase (ALT) greater than 3X ULN, and/or serum total bilirubin greater than 2.0 mg/dL.
Calculated glomerular filtration rate less than 80 mL/min based on the Schwartz Formula
Presence or history of uncontrolled hypertension: systolic pressure greater than 145 mmHg and/or diastolic pressure greater than 95 mmHg, hypertensive disorders of pregnancy, hypertension post-partum and in the puerperium
History of surgery that may affect drug bioavailability, including but not limited to cholecystectomy
Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
Symptoms and/or history of serious psychiatric or psychotic disorders
Presence of significant heart disease or disorder according to ECG
Presence of malignancy, particularly pituitary gland malignancy and prolactinoma
Presence or history of migraine headache or syncope
Pregnant according to a positive serum pregnancy test or lactating
Females less then four months post-partum
Current history of illicit drug dependency, use or alcohol abuse (greater than 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
Use of drugs for the treatment of ADD and ADHD
Inhaled corticosteroid use other than as a rescue treatment in case of asthma attack. Use of oral glucocorticoids. Use of oral steroids within the 60 days prior to study entry.
Any clinically significant illness in the previous 28 days before day 1 of this study
Use of any cytochrome P450 (CYP) 3A4 enzyme-modifying drugs, including strong inhibitors of CYP 3A4 enzymes and strong inducers of CYP3A4 enzymes (such as barbiturates, carbamazepine, phenytoin and rifampin), in the previous 28 days before Day 1 of this study
Participation in another clinical trial or donation of 50 mL or more of blood in the previous 42 days before day 1 of this study
Donation of 500 mL or more of blood in the previous 56 days before Day 1 of this study, as well as donation in excess of 900 mL of blood over the previous 20 weeks
Positive urine screening of drugs of abuse
Positive results to HIV, HBsAg or anti-HCV tests

Where it is running

Hope Research Institute, Llc — Phoenix, Arizona, United States
Yale Center for Clinical Investigation — New Haven, Connecticut, United States
Columbus Clinical Services LLC — Miami, Florida, United States
The Children's Mercy Hospital — Kansas City, Missouri, United States
Children's Hosptial of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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