Clinical trial NCT01055834: A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Official title: A Bioequivalence Study of Different Formulations of SEP-190 and Food Effect Study in Japanese Healthy Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Keywords: Insomnia
primary insomnia
insomnia associated with psychiatric or physical disorder(s)
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.


Eligibility criteria: Inclusion criteria;

1. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will
2. Japanese healthy male adult volunteers
3. Participants who are between 20 and 54 years of age at the time of obtaining written consent
4. Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening

Exclusion criteria;

1. Participants with a present illness or history of allergy to drug or food, or seasonal allergy
2. Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
3. Participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions
4. Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
5. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or those who are human immunodeficiency virus (HIV)-positive, or those who are positive for syphilis screen
6. Participants who underwent blood transfusion within 12 weeks prior to, those whose 400 mL or more of whole blood was collected within 12 weeks prior to, or those whose 200 mL or more of whole blood was collected within 4 week prior to study drug administration

Primary outcomes:
measure: Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
timeFrame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
measure: Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
timeFrame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
measure: Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
timeFrame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
measure: Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
timeFrame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Sumida
country: Japan
state: Tokyo
Study officials:
affiliation: Japan Clinical Pharmacology, Eisai Co., Ltd.
name: Kenya Nakai
role: STUDY_DIRECTOR
References: