Healthy ParticipantsPhase 1NCT03627936
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
A Phase 1 study testing Lorcaserin manufactured at Zofingen and Lorcaserin manufactured at Kawashima in people with Healthy Participants, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lorcaserin manufactured at Zofingen and Lorcaserin manufactured at Kawashima
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 2 Sep 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking, healthy participants at the time of informed consent.
- Body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) (inclusive) at Screening.
Who cannot join
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing.
- Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug, cotinine, or alcohol test at Screening or Baseline.
- Participants who contravene the restrictions on concomitant medications, food and beverages.
- Currently enrolled in another clinical study or used any investigational drug or device within 4 weeks preceding informed consent.
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen Under Fasted Conditions in Healthy Subjects
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
- Conditions
- Healthy Participants
- Being tested
- Lorcaserin manufactured at Zofingen, Lorcaserin manufactured at Kawashima
- Keywords
- Lorcaserin, Bioequivalence, Extended release, Tablets, Phase 1, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorcaserin manufactured at ZofingenDrug
Also called BELVIQ XR, APD356
Lorcaserin XR tablets manufactured at Zofingen.
Lorcaserin manufactured at KawashimaDrug
Also called BELVIQ XR, APD356
Lorcaserin XR tablets manufactured at Kawashima.
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B) | Experimental | Participants will receive a single oral dose of lorcaserin 20 milligram (mg) XR tablets manufactured at Zofingen (A) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Kawashima (B) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods. Receives: Drug: Lorcaserin manufactured at Zofingen; Drug: Lorcaserin manufactured at Kawashima |
| Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A) | Experimental | Participants will receive a single oral dose of lorcaserin 20 mg XR tablets manufactured at Kawashima (B) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Zofingen (A) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods. Receives: Drug: Lorcaserin manufactured at Zofingen; Drug: Lorcaserin manufactured at Kawashima |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Lorcaserin
Measured: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC [0-t]) of Lorcaserin
Measured: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC [0-inf]) of Lorcaserin
Measured: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Area under the concentration-time curve from zero time to 72 hour (AUC [0-72h]) of Lorcaserin
Measured: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, and 72 hours postdose in each treatment period; treatment period length = 4 days
Time to Maximum Observed Plasma Concentration (tmax) of Lorcaserin
Measured: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Terminal elimination phase half-life (t½) of Lorcaserin
Measured: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Secondary outcomes (4)
Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Measured: Baseline up to 28 days after last dose of study drug (Day 35)
Number of Participants With Markedly Abnormal Laboratory Values
Measured: Baseline up to Day 11
Number of Participants With Change From Baseline in Vital Signs Parameters
Measured: Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11
Number of Participants With Clinically Significant Findings in Physical examinations
Measured: Baseline and Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start7 Aug 2018
- Primary completion2 Sep 2018
- Study completion2 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT03627936
- Sponsor's protocol ID
- APD356-A001-040
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen Under Fasted Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03627936
- Acronym / sponsor ID
- APD356-A001-040
- Conditions
- Healthy Participants
- Keywords
- Lorcaserin, Bioequivalence, Extended release, Tablets, Phase 1, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Sep 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- 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 demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B) | Experimental | Drug: Lorcaserin manufactured at Zofingen, Drug: Lorcaserin manufactured at KawashimaParticipants will receive a single oral dose of lorcaserin 20 milligram (mg) XR tablets manufactured at Zofingen (A) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Kawashima (B) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods. |
| Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A) | Experimental | Drug: Lorcaserin manufactured at Zofingen, Drug: Lorcaserin manufactured at KawashimaParticipants will receive a single oral dose of lorcaserin 20 mg XR tablets manufactured at Kawashima (B) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Zofingen (A) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-smoking, healthy participants at the time of informed consent.
- Body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) (inclusive) at Screening.
Key exclusion criteria (6 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing.
- Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug, cotinine, or alcohol test at Screening or Baseline.
- Participants who contravene the restrictions on concomitant medications, food and beverages.
- Currently enrolled in another clinical study or used any investigational drug or device within 4 weeks preceding informed consent.
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 manufactured at ZofingenAlso: BELVIQ XR, APD356Lorcaserin XR tablets manufactured at Zofingen. | Drug | Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A), Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B) |
| Lorcaserin manufactured at KawashimaAlso: BELVIQ XR, APD356Lorcaserin XR tablets manufactured at Kawashima. | Drug | Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A), Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B) |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Lorcaserin
Time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC [0-t]) of Lorcaserin
Time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC [0-inf]) of Lorcaserin
Time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Area under the concentration-time curve from zero time to 72 hour (AUC [0-72h]) of Lorcaserin
Time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, and 72 hours postdose in each treatment period; treatment period length = 4 days
Time to Maximum Observed Plasma Concentration (tmax) of Lorcaserin
Time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Terminal elimination phase half-life (t½) of Lorcaserin
Time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
4 secondary outcomes
Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time frame: Baseline up to 28 days after last dose of study drug (Day 35)
Number of Participants With Markedly Abnormal Laboratory Values
Time frame: Baseline up to Day 11
Number of Participants With Change From Baseline in Vital Signs Parameters
Time frame: Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11
Number of Participants With Clinically Significant Findings in Physical examinations
Time frame: Baseline and Day 11
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 17 Oct 2018.
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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 Lorcaserin manufactured at Zofingen and Lorcaserin manufactured at Kawashima in people with Healthy Participants, 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 2 inclusion and 6 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 17 Oct 2018. 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?
Maximum Observed Plasma Concentration (Cmax) of Lorcaserin (time frame: predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 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 17 Oct 2018.