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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627936
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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
Healthy Participants Drug: Lorcaserin manufactured at Zofingen Drug: Lorcaserin manufactured at Kawashima Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 7, 2018
Actual Primary Completion Date : September 2, 2018
Actual Study Completion Date : September 2, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin

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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. Number of Participants With Markedly Abnormal Laboratory Values [ Time Frame: Baseline up to Day 11 ]
  3. 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 ]
  4. Number of Participants With Clinically Significant Findings in Physical examinations [ Time Frame: Baseline and Day 11 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627936


Locations
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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03627936    
Other Study ID Numbers: APD356-A001-040
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: August 2018

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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