HealthyPhase 1NCT01880502
Pharmacokinetic Study of Belviq in Adult Korean Volunteers
A Phase 1 study testing Belviq 10mg and Belviq 20mg in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I) to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Belviq 10mg and Belviq 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Oct 2013
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy adult aged 18 ~ 60 years old at the time of screening.
- Subject has body weight index (BMI) 23.0 ~ 32.0.
- ☞ BMI(kg/m2) = weight (kg)/{height (m)}2
- Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- Vital sign Supine SBP (mmHg) 90-140 DBP (mmHg) 50-90 Heart rate (beat/min) 40-80 Respiratory rate (breaths/min) 8-18
- Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
- SBP(mmHg) 90-140 DBP(mmHg) 50-90 Heart rate (beat/min) 40-80 Respiratory rate (breaths/min) 8-18
- Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.
Who cannot join
- Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
- Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
- Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
- Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test (performed during screening and on Day -1).
- Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug or vitamins within 1 week prior to the first medication or paracetamol 48 hours prior to taking the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator).
- Subject participated in another study and received medication within 3 months prior to the first medication day (3 months are judged to be the period in between medications).
Show all 18Show fewer
- Subject has history of using the following drug
- Fenfluramine/dexfenfluramine or phentermine
- Drug that may increase the risk of valvulopathy or primary pulmonary hypertension (Cyproheptadine, Trazodone, Nefazodone, Amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide).
- Subject received whole blood transfusion (500 mL) within 3 months prior to the first medication or blood transfusion within 1 month prior to the first medication.
- Subject continually drinks (in excess of 28 units/week (21 unit/week for women), 1 unit = 10 g of pure alcohol) or cannot abstain from drinking for 48 hours prior to the study drug administration through the hospitalization period.
- Subject smokes 3 cigarettes or more in one day or cannot abstain from smoking for 48 hours prior to the study drug administration through the hospitalization period.
- Subject took caffeine-containing food within 48 hours prior to the first medication, or cannot abstain from taking during the hospitalization period.
- Subject has tested positive to HbsAg, HCV Ab, HIV Ab tests.
- Subject has peculiar diet, is a vegetarian or consumes food that may affect the drug metabolism (e.g. St. John's Wort).
- Subject had serious change in dietary habit or activity from 4 weeks prior to the study drug administration.
- Subject or his/her partner cannot or is not willing to use appropriate contraceptives during the trial period and for 28 days after termination of the study (for women, exclusion criteria include pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test).
- Subject was judged not to be eligible according to the discretion of the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Jongno-gu, Seoul, 110-744
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study (Phase I) to Evaluate the Tolerability and Pharmacokinetics of Belviq in Adult Korean Volunteers
A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I) to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.
Read the detailed description
The volunteers are screened through medical history, physical exam, laboratory tests etc. within 4 weeks (-28d~-2d) prior to the day scheduled for taking the investigational product (1d). The final subjects determined eligible for this clinical trial through screening tests are randomized to the dose groups with Belviq 10 mg and 20 mg. Twelve subjects are assigned to each group (9 subjects to study drug and 3 subjects to placebo), and the study drug or placebo are administered to the corresponding administration group. The subjects are discharged on the morning of 4d after completing the set study schedule at 72 hours after administration. The subjects then visit for the final tests on the last out-patient visiting day. Belviq is progressed sequentially from the low-dose group to the high-dose group.
The blood sampling time for the pharmacokinetic evaluation is as follows. Blood sampling for pharmacokinetic evaluation
: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
- Conditions
- Healthy
- Being tested
- Belviq 10mg, Belviq 20mg, Placebo
- Keywords
- Healthy, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belviq 10mgDrug
Belviq 10mg single dose administration
Belviq 20mgDrug
Belviq 20mg single dose administration
PlaceboDrug
Placebo single dose administration
| Study group | Role | What they receive |
|---|---|---|
| Belviq 10mg | Experimental | Not described Receives: Drug: Belviq 10mg |
| Belviq 20mg | Experimental | Not described Receives: Drug: Belviq 20mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
adverse event
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
electrocardiography
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
clinical laboratory tests
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
physical exam
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
echocardiography
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Secondary outcomes (3)
Change in Belviq concentration in the blood with time
Measured: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D, tmax, t1/2 of Belviq
Measured: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
CL/F, Vz/F of Belviq
Measured: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoung Sang You, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880502
- Sponsor's protocol ID
- ID_Belviq_1301
- Status last verified
- Oct 2013
- First submitted
- 12 Jun 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study (Phase I) to Evaluate the Tolerability and Pharmacokinetics of Belviq in Adult Korean Volunteers
- ClinicalTrials.gov ID
- NCT01880502
- Acronym / sponsor ID
- ID_Belviq_1301
- Conditions
- Healthy
- Keywords
- Healthy, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Jun 2013 (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.
A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I) to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.
Detailed description
The volunteers are screened through medical history, physical exam, laboratory tests etc. within 4 weeks (-28d~-2d) prior to the day scheduled for taking the investigational product (1d). The final subjects determined eligible for this clinical trial through screening tests are randomized to the dose groups with Belviq 10 mg and 20 mg. Twelve subjects are assigned to each group (9 subjects to study drug and 3 subjects to placebo), and the study drug or placebo are administered to the corresponding administration group. The subjects are discharged on the morning of 4d after completing the set study schedule at 72 hours after administration. The subjects then visit for the final tests on the last out-patient visiting day. Belviq is progressed sequentially from the low-dose group to the high-dose group.
The blood sampling time for the pharmacokinetic evaluation is as follows. Blood sampling for pharmacokinetic evaluation
: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Belviq 10mg | Experimental | Drug: Belviq 10mg |
| Belviq 20mg | Experimental | Drug: Belviq 20mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is a healthy adult aged 18 ~ 60 years old at the time of screening.
- Subject has body weight index (BMI) 23.0 ~ 32.0.
- ☞ BMI(kg/m2) = weight (kg)/{height (m)}2
- Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- Vital sign Supine SBP (mmHg) 90-140 DBP (mmHg) 50-90 Heart rate (beat/min) 40-80 Respiratory rate (breaths/min) 8-18
Key exclusion criteria (18 listed)
- Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
- Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
- Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
- Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test (performed during screening and on Day -1).
- Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug or vitamins within 1 week prior to the first medication or paracetamol 48 hours prior to taking the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator).
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 |
|---|---|---|
| Belviq 10mgBelviq 10mg single dose administration | Drug | Belviq 10mg |
| Belviq 20mgBelviq 20mg single dose administration | Drug | Belviq 20mg |
| PlaceboPlacebo single dose administration | Drug | Placebo |
Primary outcome
Vital signs
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
adverse event
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
electrocardiography
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
clinical laboratory tests
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
physical exam
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
echocardiography
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
3 secondary outcomes
Change in Belviq concentration in the blood with time
Time frame: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D, tmax, t1/2 of Belviq
Time frame: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication.
CL/F, Vz/F of Belviq
Time frame: Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h (17 times) after medication
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 14 Oct 2013.
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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.
Kyoung Sang You, MD, PhD principal investigator
Seoul National University Hospital
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 Belviq 10mg and Belviq 20mg in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
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 18 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 14 Oct 2013. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Vital signs (time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days). The study lists 6 primary outcomes in all. 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 14 Oct 2013.