Clinical trial NCT03627936: A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Lorcaserin
Bioequivalence
Extended release
Tablets
Phase 1
Healthy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Lorcaserin
timeFrame: 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
measure: Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC [0-t]) of Lorcaserin
timeFrame: 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
measure: Area under the concentration-time curve from zero time extrapolated to infinite time (AUC [0-inf]) of Lorcaserin
timeFrame: 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
measure: Area under the concentration-time curve from zero time to 72 hour (AUC [0-72h]) of Lorcaserin
timeFrame: 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
measure: Time to Maximum Observed Plasma Concentration (tmax) of Lorcaserin
timeFrame: 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
measure: Terminal elimination phase half-life (t½) of Lorcaserin
timeFrame: 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:
measure: Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
timeFrame: Baseline up to 28 days after last dose of study drug (Day 35)
measure: Number of Participants With Markedly Abnormal Laboratory Values
timeFrame: Baseline up to Day 11
measure: Number of Participants With Change From Baseline in Vital Signs Parameters
timeFrame: Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11
measure: Number of Participants With Clinically Significant Findings in Physical examinations
timeFrame: Baseline and Day 11
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
Study officials:
References: