Clincosm LogoSign in Get a demo

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

Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03627936
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
26
Actual Duration (Days)
46.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lorcaserin manufactured at Zofingen
  • Drug: Lorcaserin manufactured at Kawashima
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Aug 7, 2018
Actual Primary Completion Date :
Sep 2, 2018
Actual Study Completion Date :
Sep 2, 2018

Arms and Interventions

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:
  • BELVIQ XR
  • APD356

    • Drug: Lorcaserin manufactured at Kawashima
    Lorcaserin XR tablets manufactured at Kawashima.
    Other Names:
  • BELVIQ XR
  • APD356

    		•
    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:
  • BELVIQ XR
  • APD356

    • Drug: Lorcaserin manufactured at Kawashima
    Lorcaserin XR tablets manufactured at Kawashima.
    Other Names:
  • BELVIQ XR
  • APD356

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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]

    5. 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]

    6. 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

    1. 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)]

    2. Number of Participants With Markedly Abnormal Laboratory Values [Baseline up to Day 11]

    3. 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]

    4. Number of Participants With Clinically Significant Findings in Physical examinations [Baseline and Day 11]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Worldwide Clinical Trials San Antonio Texas United States 78217

    Sponsors and Collaborators

    • Eisai Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Inc.
    ClinicalTrials.gov Identifier:
    NCT03627936
    Other Study ID Numbers:
    • APD356-A001-040
    First Posted:
    Aug 14, 2018
    Last Update Posted:
    Oct 17, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eisai Inc.
    Lorcaserin
    Bioequivalence
    Extended release
    Tablets
    Phase 1
    Healthy

    Study Results

    No Results Posted as of Oct 17, 2018