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

NCT03627936 | Completed Phase 1 FDA Drug

• 1 other identifier: APD356-A001-040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Lorcaserin; Bioequivalence; Extended release; Tablets; Phase 1; Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

Study Arms (2)

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.

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.

Drug: Lorcaserin manufactured at Zofingen; Drug: Lorcaserin manufactured at Kawashima

Interventions

Lorcaserin manufactured at Zofingen DRUG

Lorcaserin XR tablets manufactured at Zofingen.

Also known as: BELVIQ XR, APD356

Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A); Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B)

Lorcaserin manufactured at Kawashima DRUG

Lorcaserin XR tablets manufactured at Kawashima.

Also known as: BELVIQ XR, APD356

Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A); Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

lorcaserin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: August 7, 2018
• Primary Completion: September 2, 2018
• Study Completion: September 2, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-08

Locations

US (1)