A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02088697
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 49.1

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Placebo; Drug: ASC-01	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASC-01 placebo A single oral dose of ASC-01 Placebo (sertraline 100 mg)	Drug: Placebo
Active Comparator: Sertraline tablet A single oral dose of sertraline tablets (sertraline 100 mg)	Drug: ASC-01

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration (Cmax) of Sertraline [predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose]

Secondary Outcome Measures

1. Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline [predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male volunteers aged 20 to 40 years.

• Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.

Exclusion Criteria:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.

• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

• Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osaka Pharmacology Clinical research Hospital	Osaka		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02088697
• Other Study ID Numbers: 031-13-003
• First Posted: Mar 17, 2014
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

Study Results

Participant Flow

Arm/Group Title	Arm A: ASC-01 Placebo First	Arm B: Sertraline First
Arm/Group Description	Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting. Period II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.	Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting. Period II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting.
Period Title: Period I
STARTED	25	25
COMPLETED	24	21
NOT COMPLETED	1	4
Period Title: Period I
STARTED	24	21
COMPLETED	23	21
NOT COMPLETED	1	0
Period Title: Period I
STARTED	23	21
COMPLETED	23	21
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm A: ASC-01 Placebo First	Arm B: Sertraline First	Total
Arm/Group Description	Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting. Period II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.	Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting. Period II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting.	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.2 (3.7)	28.5 (4.3)	26.8 (4.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	25 100%	25 100%	50 100%
Race/Ethnicity, Customized (Count of Participants)
Japanese	25 100%	25 100%	50 100%
Region of Enrollment (Count of Participants)
Japan	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Peak Plasma Concentration (Cmax) of Sertraline
Time Frame	predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose

Outcome Measure Data

Analysis Population Description

Bioequivalence Analysis Set comprised all subjects for whom the Cmax and AUCt were determined in both Period I and Period II.

Arm/Group Title	ASC-01 Placebo	Sertraline
Arm/Group Description	A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.	A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.
Measure Participants	44	44
Mean (Standard Deviation) [ng/mL]	28.3 (8.31)	28.8 (10.1)

2. Secondary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline
Time Frame	predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose

Outcome Measure Data

Analysis Population Description

Bioequivalence Analysis Set comprised all subjects for whom the Cmax and AUCt were determined in both Period I and Period II.

Arm/Group Title	ASC-01 Placebo	Sertraline
Arm/Group Description	A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.	A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.
Measure Participants	44	44
Mean (Standard Deviation) [ng*h/mL]	835 (363)	856 (421)

Adverse Events

Time Frame	Treatment-emergent adverse events occurring up to 8 days after dosing date were collected.
Adverse Event Reporting Description	A single dose of ASC-01 placebo or sertraline tablet was administered to 25 subjects each in Period I, and a single dose of ASC-01 placebo or sertraline tablet was administered to 21 and 23 subjects, respectively, in Period II. In this trial, safety data for each formulation were summarized based on subjects treated with the respective formulation, and safety was therefore evaluated in 46 subjects receiving ASC-01 placebo and 48 subjects receiving sertraline tablets.
Arm/Group Title	ASC-01 Placebo		Sertraline
Arm/Group Description	A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.		A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.
All Cause Mortality
	ASC-01 Placebo		Sertraline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/48 (0%)
Serious Adverse Events
	ASC-01 Placebo		Sertraline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	ASC-01 Placebo		Sertraline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/46 (19.6%)		19/48 (39.6%)
Gastrointestinal disorders
Nausea	5/46 (10.9%)		9/48 (18.8%)
Diarrhoea	3/46 (6.5%)		10/48 (20.8%)
Vomiting	0/46 (0%)		4/48 (8.3%)
General disorders
Malaise	1/46 (2.2%)		0/48 (0%)
Infections and infestations
Influenza	1/46 (2.2%)		0/48 (0%)
Investigations
Blood bilirubin increased	1/46 (2.2%)		1/48 (2.1%)
Blood sodium decreased	1/46 (2.2%)		2/48 (4.2%)
Liver function test abnormal	1/46 (2.2%)		0/48 (0%)
White blood cell count increased	1/46 (2.2%)		0/48 (0%)
Blood creatine phosphokinase increased	0/46 (0%)		1/48 (2.1%)
Eosinophil count increased	0/46 (0%)		1/48 (2.1%)
Nervous system disorders
Dizziness	1/46 (2.2%)		0/48 (0%)
Headache	1/46 (2.2%)		1/48 (2.1%)
Somnolence	0/46 (0%)		1/48 (2.1%)
Tremor	0/46 (0%)		1/48 (2.1%)
Renal and urinary disorders
Ketonuria	1/46 (2.2%)		2/48 (4.2%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/46 (0%)		1/48 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.