NCT02078440

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

January 23, 2014

Last Update Submit

August 26, 2016

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesChildrenAdolescentsBioavailabilityCyclosetBromocriptine Mesylate

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    The pharmacokinetic parameters of interest will be Cmax, AUCT and AUC∞ and Tmax. Other parameters including AUCT/∞, Kel, T½el,CL/F, and Vd, will be provided for information purposes.

    Thirty-six hours

Study Arms (1)

Bromocriptine mesylate (Cycloset)

OTHER

Bromocriptine mesylate (Cycloset)

Drug: Bromocriptine mesylate

Interventions

Bromocriptine mesylateDRUG

Cycloset (bromocriptine mesylate quick release) 0.8 mg tablets, weight adjusted 1.6 mg- 4.8 mg

Also known as: Cycloset, Bromocriptine-QR, BQR
Bromocriptine mesylate (Cycloset)

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hope Research Institute, Llc

Phoenix, Arizona, 85018, United States

Location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06511, United States

Location

Columbus Clinical Services LLC

Miami, Florida, 33165, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Children's Hosptial of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsErgolinesHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bindu Chamarthi, MD MMSc

    VeroScience

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

March 5, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

US(5)