A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Lorcaserin manufactured at Zofingen
* Drug: Lorcaserin manufactured at Kawashima


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B)<br>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. | Drug: Lorcaserin manufactured at Zofingen<br>* Lorcaserin XR tablets manufactured at Zofingen.<br>* Other names: APD356;Drug: Lorcaserin manufactured at Kawashima<br>* Lorcaserin XR tablets manufactured at Kawashima.<br>* Other names: APD356;|
| Experimental: Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A)<br>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. | Drug: Lorcaserin manufactured at Zofingen<br>* Lorcaserin XR tablets manufactured at Zofingen.<br>* Other names: APD356;Drug: Lorcaserin manufactured at Kawashima<br>* Lorcaserin XR tablets manufactured at Kawashima.<br>* Other names: APD356;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of Lorcaserin |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) |  | Baseline up to 28 days after last dose of study drug (Day 35) | 
| Number of Participants With Markedly Abnormal Laboratory Values |  | Baseline up to Day 11 | 
| Number of Participants With Change From Baseline in Vital Signs Parameters |  | Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11 | 
| Number of Participants With Clinically Significant Findings in Physical examinations |  | Baseline and Day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lorcaserin, Bioequivalence, Extended release, Tablets, Phase 1, Healthy