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 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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Lorcaserin manufactured at Zofingen; Drug: Lorcaserin manufactured at Kawashima

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Worldwide Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B); 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; Lorcaserin XR tablets manufactured at Zofingen.; Other Names: APD356; BELVIQ XR; Drug: Lorcaserin manufactured at Kawashima; Lorcaserin XR tablets manufactured at Kawashima.; Other Names: APD356; BELVIQ XR
Experimental: Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A); 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; Lorcaserin XR tablets manufactured at Zofingen.; Other Names: APD356; BELVIQ XR; Drug: Lorcaserin manufactured at Kawashima; Lorcaserin XR tablets manufactured at Kawashima.; Other Names: APD356; BELVIQ XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): September 2, 2018
• Study Completion (Actual): September 2, 2018

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Healthy; Bioequivalence; Phase 1; Tablets; Lorcaserin; Extended release
• Other Study ID Numbers: APD356-A001-040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No