ObesityPhase 1NCT02398669
A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
A Phase 1 study testing Lorcaserin hydrochloride in people with Obesity, run by Eisai Inc. at 1 site in United States.
Trial summary
Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lorcaserin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to May 2015
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females aged 6 years to 11 years (up to 11 years and 364 days), inclusive, at Screening.
- BMI greater than or equal to 99th percentile for age and gender as defined as:
- Age Boys Girls 6 21.6 23.0 7 23.6 24.6 8 25.6 26.4 9 27.6 28.2 10 29.3 29.9 11 30.7 31.5
- but less than or equal to 44kg/m2 at Screening.
- Provide written informed consent signed by parent/legal guardian prior to entering the study or undergoing any study procedures. A written or verbal assent from the subjects will also be obtained.
- Females aged at least 8 years should have a negative serum B-human chorionic gonadotropin (beta-hCG) at Visit 1 and a negative urine pregnancy test prior to receiving their first dose of study drug at Visit 2.
- Willing and able to comply with all aspects of the protocol.
- Able to swallow a single tablet.
Who cannot join
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks of dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or subjects who have a congenital abnormality in metabolism)
- Secondary (chromosomal, endocrine, or metabolic) causes of obesity (eg, Prader-Willi syndrome, Down's Syndrome, untreated hypothyroidism, or Cushing's syndrome).
- Any history of abdominal surgery that may affect PK evaluations (eg, hepatectomy, nephrotomy, digestive organ resection or any gastrointestinal procedure for the purpose of weight loss, which would slow gastric emptying).
- Any clinically relevant symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening.
- Special needs subjects who are unable to comprehend trial-related instructions (eg, mild to profound mental retardation, moderate to severe cognitive developmental delay, pervasive developmental disorders, autism).
Show all 21Show fewer
- Females who are sexually active.
- Ongoing epilepsy or other seizure disorder, or use of medications for a seizure disorder within 6 months of the Screening or between Screening and Day 1.
- History of congestive heart failure, pulmonary arterial hypertension, congenital heart disease, or organ transplantation.
- Resting heart rate less than 50 or greater than 120 beats/min at Screening or predose on Day 1.
- Systolic blood pressure (BP) greater than 140 mmHg or less than 90 mmHg or diastolic blood pressure greater than 90 mmHg or less than 60 mmHg at Screening or predose on Day 1.
- Hypersensitivity to the study drug or any of its excipients.
- Significant change in diet or level of physical activity within 1 month prior to dosing or change in weight of greater than 5 kg within 3 months prior to dosing.
- Known to be human immunodeficiency virus (HIV) positive at Screening.
- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening.
- Unable to attend scheduled visits (eg, lack of transportation) or lack of a parent/guardian to supervise study participation.
- Enrolled in another clinical trial that involved pharmacotherapy, or medical device, within 30 days before informed consent.
- Use of drugs with serotonergic activity within 4 weeks before dosing, including but not limited to selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, and drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], linezolid), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists.
- Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect cytochrome P450 activities or transporters (eg, grapefruit, grapefruit juice, grapefruit containing beverages, apple or orange juice, vegetables from the mustard green family [eg, kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard] and charbroiled meats) is prohibited within 2 weeks before dosing.
- Intake of herbal preparations containing St. John's Wort is prohibited within 4 weeks before dosing.
- Treatment within 4 weeks of dosing with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months of dosing with a prescription weight loss drug (eg, phentermine, sibutramine, orlistat) or lipid dissolving injections (eg, Lipodissolve).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Dose Study to Assess Pharmacokinetics, Safety and Tolerability of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.
- Conditions
- Obesity
- Being tested
- Lorcaserin hydrochloride
- Keywords
- Obesity, Lorcaserin hydrochloride, APD356, Pediatric, Pharmacokinetics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorcaserin hydrochlorideDrug
Also called APD356
A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| lorcaserin 10 mg | Experimental | Cohort 1 - obese pediatric participants between age group of 6 and 8 years (inclusive) Cohort 2 - obese pediatric participants between age group of 9 and 11 years (inclusive) Receives: Drug: Lorcaserin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma PK profile of lorcaserin and its primary metabolites (M1 and M5)
Measured: Day 1 at 1, 2, 3, 4, and 6 hours postdose, Day 2 (24 +/- 2 h postdose), Day 3 (48 +/- 2 h postdose), and Day 5 (96 +/- 2 h postdose)
Secondary outcomes (1)
Number of participants with Adverse Events (AEs) / Serious Adverse Events (SAEs) as a measure of safety and tolerabilty
Safety will be assessed by monitoring and recording all AEs and SAEs, monitoring hematology, blood chemistry and urine values, measuring vital signs and ECG, and the performing physical examinations.
Measured: From signing of informed consent until 30 days from participant's last dose or until resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398669
- Sponsor's protocol ID
- APD356-A001-026
- Status last verified
- Nov 2015
- First submitted
- 20 Mar 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose Study to Assess Pharmacokinetics, Safety and Tolerability of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
- ClinicalTrials.gov ID
- NCT02398669
- Acronym / sponsor ID
- APD356-A001-026
- Conditions
- Obesity
- Keywords
- Obesity, Lorcaserin hydrochloride, APD356, Pediatric, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Mar 2015 (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.
Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lorcaserin 10 mg | Experimental | Drug: Lorcaserin hydrochlorideCohort 1 - obese pediatric participants between age group of 6 and 8 years (inclusive) Cohort 2 - obese pediatric participants between age group of 9 and 11 years (inclusive) |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Males and females aged 6 years to 11 years (up to 11 years and 364 days), inclusive, at Screening.
- BMI greater than or equal to 99th percentile for age and gender as defined as:
- Age Boys Girls 6 21.6 23.0 7 23.6 24.6 8 25.6 26.4 9 27.6 28.2 10 29.3 29.9 11 30.7 31.5
- but less than or equal to 44kg/m2 at Screening.
- Provide written informed consent signed by parent/legal guardian prior to entering the study or undergoing any study procedures. A written or verbal assent from the subjects will also be obtained.
Key exclusion criteria (21 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks of dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or subjects who have a congenital abnormality in metabolism)
- Secondary (chromosomal, endocrine, or metabolic) causes of obesity (eg, Prader-Willi syndrome, Down's Syndrome, untreated hypothyroidism, or Cushing's syndrome).
- Any history of abdominal surgery that may affect PK evaluations (eg, hepatectomy, nephrotomy, digestive organ resection or any gastrointestinal procedure for the purpose of weight loss, which would slow gastric emptying).
- Any clinically relevant symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening.
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 |
|---|---|---|
| Lorcaserin hydrochlorideAlso: APD356A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water. | Drug | lorcaserin 10 mg |
Primary outcome
Plasma PK profile of lorcaserin and its primary metabolites (M1 and M5)
Time frame: Day 1 at 1, 2, 3, 4, and 6 hours postdose, Day 2 (24 +/- 2 h postdose), Day 3 (48 +/- 2 h postdose), and Day 5 (96 +/- 2 h postdose)
1 secondary outcome
Number of participants with Adverse Events (AEs) / Serious Adverse Events (SAEs) as a measure of safety and tolerabilty
Time frame: From signing of informed consent until 30 days from participant's last dose or until resolution
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 3 Nov 2015.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lorcaserin hydrochloride in people with Obesity, run by Eisai Inc. at 1 site 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 8 inclusion and 21 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Plasma PK profile of lorcaserin and its primary metabolites (M1 and M5) (time frame: Day 1 at 1, 2, 3, 4, and 6 hours postdose, Day 2 (24 +/- 2 h postdose), Day 3 (48 +/- 2 h postdose), and Day 5 (96 +/- 2 h postdose)). 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 3 Nov 2015.