Healthy SubjectsPhase 1NCT02192515
A Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects
A Phase 1 study testing APD356 10 mg, APD356 XR-20 mg and APD356 20 mg in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center, placebo-controlled, randomized,double-blind study. Read more about this study
- Who is it for?
- Ages 20 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- APD356 10 mg, APD356 XR-20 mg and APD356 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Jan 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 20 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in this study:
- Non-smoking, healthy Japanese male subjects age greater than or equal to 20 years and less than 55 years old at the time of informed consent. To be considered non-smokers, subject must have discontinued smoking for at least 4 weeks prior to dosing.
- BMI greater than or equal to 23 and less than 32 kg/m2 at Screening
- BMI (kg/m2) = body weight(kg)/[height(m) x height(m)]
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism
- Any history of gastrointestinal surgery that may affect PK profiles of study drug, eg, hepatectomy, nephrotomy, digestive organ resection at Screening
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening
- A prolonged QT/QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening or Baseline
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- Known history of clinically significant drug allergy at Screening
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
- Known to be human immunodeficiency virus (HIV) positive at Screening
- Positive results for Hepatitis B surface antigen (HBs Ag), Hepatitis C virus antibody (HCV Ab) or Syphilis test at Screening
- History of drug or alcohol dependency or abuse, or those who have a positive urine drug test at Screening or Baseline
- Intake of caffeinated beverages or food within 72 hours prior to dosing
- Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (eg, alcohol and grapefruit juice) within 1 week prior to dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks prior to dosing
- Use of prescription drugs (except for disinfectants, eye drops) within 4 weeks prior to dosing
- Intake of over-the-counter (OTC) medications (except for disinfectants, eye drops) within 2 weeks prior to dosing
- Currently enrolled in another clinical study or used any investigational drug or device within 16 weeks preceding informed consent
- Subjects who undergo blood transfusion within 12 weeks, or who donate 400 mL or more of whole blood within 12 weeks (16 weeks for woman) or 200 mL or more of whole blood within 4 weeks, or who make a component donation within 2 weeks prior to dosing.
- Engagement in strenuous exercise within 2 weeks prior to check-in (eg, marathon runners, weight lifters, etc.)
- Subjects who have any condition that would make them, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects
The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center, placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single center, randomized, open-label study that consists of two sequential two-way crossover studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
- Conditions
- Healthy Subjects
- Being tested
- APD356 10 mg, APD356 XR-20 mg, APD356 10 mg matching Placebo, APD356 XR-20 mg matching Placebo, APD356 20 mg
- Keywords
- Healthy Subjects, Japanese Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD356 10 mgDrug
One tablet of APD356 10 mg will be orally administered in fasted state.
APD356 XR-20 mgDrug
One tablet of APD356 XR-20 mg will be orally administered in fasted state.
APD356 10 mg matching PlaceboDrug
One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.
APD356 XR-20 mg matching PlaceboDrug
One tablet of APD356 XR matching placebo will be orally administered in fasted state.
APD356 20 mgDrug
Two tablets of APD356 10 mg will be orally administered in fasted state.
APD356 20 mg matching PlaceboDrug
Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.
APD356 XR-20 mg (orange tablet)Drug
One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.
APD356 XR-20mg (orange tablet, fed state)Drug
One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.
| Study group | Role | What they receive |
|---|---|---|
| APD356 10 mg | Experimental | Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. Receives: Drug: APD356 10 mg; Drug: APD356 10 mg matching Placebo |
| APD356 20 mg | Experimental | Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. Receives: Drug: APD356 20 mg; Drug: APD356 20 mg matching Placebo |
| APD356 XR-20 mg | Experimental | Subjects will be randomized to APD356 XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. Receives: Drug: APD356 XR-20 mg; Drug: APD356 XR-20 mg matching Placebo |
| APD356 10 mg and APD356 XR-20mg (orange tablet) | Experimental | Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted) Receives: Drug: APD356 10 mg; Drug: APD356 XR-20 mg (orange tablet); Drug: APD356 XR-20mg (orange tablet, fed state) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs
Measured: Up to 30 days after last dose
Pharmacokinetics of APD356: Cmax
Measured: Up to 96 hours after last dose
Pharmacokinetics of APD356: tmax
Measured: Up to 96 hours after last dose
Pharmacokinetics of APD356: AUC
Measured: Up to 96 hours after last dose
Pharmacokinetics of APD356: t1/2
Measured: Up to 96 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192515
- Sponsor's protocol ID
- APD356-J081-101
- Status last verified
- Feb 2016
- First submitted
- 15 Jul 2014
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects
- ClinicalTrials.gov ID
- NCT02192515
- Acronym / sponsor ID
- APD356-J081-101
- Conditions
- Healthy Subjects
- Keywords
- Healthy Subjects, Japanese Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jul 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 purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center, placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single center, randomized, open-label study that consists of two sequential two-way crossover studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| APD356 10 mg | Experimental | Drug: APD356 10 mg, Drug: APD356 10 mg matching PlaceboSubjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. |
| APD356 20 mg | Experimental | Drug: APD356 20 mg, Drug: APD356 20 mg matching PlaceboSubjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. |
| APD356 XR-20 mg | Experimental | Drug: APD356 XR-20 mg, Drug: APD356 XR-20 mg matching PlaceboSubjects will be randomized to APD356 XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. |
| APD356 10 mg and APD356 XR-20mg (orange tablet) | Experimental | Drug: APD356 10 mg, Drug: APD356 XR-20 mg (orange tablet), Drug: APD356 XR-20mg (orange tablet, fed state)Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below. Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed) Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted) |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking, healthy Japanese male subjects age greater than or equal to 20 years and less than 55 years old at the time of informed consent. To be considered non-smokers, subject must have discontinued smoking for at least 4 weeks prior to dosing.
- BMI greater than or equal to 23 and less than 32 kg/m2 at Screening
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Key exclusion criteria (20 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism
- Any history of gastrointestinal surgery that may affect PK profiles of study drug, eg, hepatectomy, nephrotomy, digestive organ resection at Screening
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening
- A prolonged QT/QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening or Baseline
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 |
|---|---|---|
| APD356 10 mgOne tablet of APD356 10 mg will be orally administered in fasted state. | Drug | APD356 10 mg, APD356 10 mg and APD356 XR-20mg (orange tablet) |
| APD356 XR-20 mgOne tablet of APD356 XR-20 mg will be orally administered in fasted state. | Drug | APD356 XR-20 mg |
| APD356 10 mg matching PlaceboOne tablet of APD356 10 mg matching placebo will be orally administered in fasted state. | Drug | APD356 10 mg |
| APD356 XR-20 mg matching PlaceboOne tablet of APD356 XR matching placebo will be orally administered in fasted state. | Drug | APD356 XR-20 mg |
| APD356 20 mgTwo tablets of APD356 10 mg will be orally administered in fasted state. | Drug | APD356 20 mg |
| APD356 20 mg matching PlaceboTwo tablets of APD356 10 mg matching placebo will be orally administered in fasted state. | Drug | APD356 20 mg |
| APD356 XR-20 mg (orange tablet)One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state. | Drug | APD356 10 mg and APD356 XR-20mg (orange tablet) |
| APD356 XR-20mg (orange tablet, fed state)One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal. | Drug | APD356 10 mg and APD356 XR-20mg (orange tablet) |
Primary outcome
Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs
Time frame: Up to 30 days after last dose
Pharmacokinetics of APD356: Cmax
Time frame: Up to 96 hours after last dose
Pharmacokinetics of APD356: tmax
Time frame: Up to 96 hours after last dose
Pharmacokinetics of APD356: AUC
Time frame: Up to 96 hours after last dose
Pharmacokinetics of APD356: t1/2
Time frame: Up to 96 hours after last dose
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 10 Feb 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.
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 APD356 10 mg, APD356 XR-20 mg and APD356 20 mg in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in Japan.
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 6 inclusion and 20 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 10 Feb 2016. 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 Japan. 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?
Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs (time frame: Up to 30 days after last dose). The study lists 5 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 10 Feb 2016.