Type 2 DiabetesPhase 1NCT02078440
Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects
A Phase 1 study testing Bromocriptine mesylate in people with Type 2 Diabetes, run by VeroScience at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Bromocriptine mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Columbus Clinical Services LLC
Miami, Florida, 33165
Yale Center for Clinical Investigation
New Haven, Connecticut, 06511
Children's Hosptial of Philadelphia
Philadelphia, Pennsylvania, 19104
Hope Research Institute, Llc
Phoenix, Arizona, 85018
About this study
Official title: Single Dose Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets Following Administration of a Weight-Adjusted Dose in Male and Female Children and Adolescent Type 2 Diabetes Mellitus Subjects VS-PEDS BA-2010-V4
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Bromocriptine mesylate
- Keywords
- Type 2 Diabetes, Children, Adolescents, Bioavailability, Cycloset, Bromocriptine Mesylate
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromocriptine mesylateDrug
Also called Cycloset, Bromocriptine-QR, BQR
Cycloset (bromocriptine mesylate quick release) 0.8 mg tablets, weight adjusted 1.6 mg- 4.8 mg
| Study group | Role | What they receive |
|---|---|---|
| Bromocriptine mesylate (Cycloset) | Other | Bromocriptine mesylate (Cycloset) Receives: Drug: Bromocriptine mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Thirty-six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeroScience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bindu Chamarthi, MD MMSc, Study director, VeroScience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078440
- Sponsor's protocol ID
- VS-PEDS BA-2010
- Status last verified
- Aug 2016
- First submitted
- 23 Jan 2014
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets Following Administration of a Weight-Adjusted Dose in Male and Female Children and Adolescent Type 2 Diabetes Mellitus Subjects VS-PEDS BA-2010-V4
- ClinicalTrials.gov ID
- NCT02078440
- Acronym / sponsor ID
- VS-PEDS BA-2010
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Children, Adolescents, Bioavailability, Cycloset, Bromocriptine Mesylate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- VeroScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bromocriptine mesylate (Cycloset) | Other | Drug: Bromocriptine mesylateBromocriptine mesylate (Cycloset) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromocriptine mesylateAlso: Cycloset, Bromocriptine-QR, BQRCycloset (bromocriptine mesylate quick release) 0.8 mg tablets, weight adjusted 1.6 mg- 4.8 mg | Drug | Bromocriptine mesylate (Cycloset) |
Primary outcome
Pharmacokinetics
Time frame: Thirty-six hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bindu Chamarthi, MD MMSc study director
VeroScience
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bromocriptine mesylate in people with Type 2 Diabetes, run by VeroScience at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: Thirty-six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.