Healthy Male AdultsPhase 1NCT03342963

Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults

A Phase 1 study testing ASC-01 and Aripiprazole and sertraline in people with Healthy Male Adults, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1). Read more about this study

Who is it for?: Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Adults
What is being tested?: ASC-01 and Aripiprazole and sertraline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteJapan
Study dates: 21 Nov 2017to 18 Jan 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subject at the age between 20 and 40 at the time of informed consent
Subject has a body mass index (BMI = body weight [kg]/height [m]2) of ≥18.5 and <25.0 kg/m2 at screening
Subject is providing consent for participation in this trial in writing prior to the start of the procedures related to this trial, and judged by the investigator or subinvestigator to be capable of observing procedures in this trial.

Who cannot join

Subject has a clinically significant abnormality in physical findings at screening or in medical history that in the investigator's or subinvestigator's opinion may place the subject at risk or interfere with outcome variables including drug absorption, distribution, metabolism, and excretion.
Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Clinic of Kyusyu Region
Fukuoka

Other trials in Japan

About this study

Official title: A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults

To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).

Conditions: Healthy Male Adults
Being tested: ASC-01, Aripiprazole and sertraline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASC-01Drug
Aripiprazole 3 mg/sertraline 100 mg combination drug
Aripiprazole and sertralineDrug
Aripiprazole 3 mg and sertraline 100 mg

Study groups in NCT03342963
Study group	Role	What they receive
ASC-01 in period 1, Aripiprazole and sertraline in period 2	Experimental	At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. Receives: Drug: ASC-01; Drug: Aripiprazole and sertraline
Aripiprazole and sertraline in period 1, ASC-01 in period 2	Experimental	At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. Receives: Drug: ASC-01; Drug: Aripiprazole and sertraline
Fasting in period 1, After breakfast in period 2	Experimental	At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. Receives: Drug: ASC-01; Drug: Aripiprazole and sertraline
After breakfast in period 1, Fasting in period 2	Experimental	At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. Receives: Drug: ASC-01; Drug: Aripiprazole and sertraline

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1
Measured: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1
Measured: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Cmax of Aripiprazole and Sertraline in Cohort 2
Measured: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
AUC168h of Aripiprazole and Sertraline in Cohort 2
Measured: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 201718 Jan 2018

First posted17 Nov 2017
Study start21 Nov 2017
Primary completion18 Jan 2018
Study completion18 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Male AdultsStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03342963
Sponsor's protocol ID: 031-102-00214
Other IDs: JapicCTI-173774
Status last verified: Apr 2021
First submitted: 8 Nov 2017
Last updated: 3 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Male Adults trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
ClinicalTrials.gov ID: NCT03342963
Acronym / sponsor ID: 031-102-00214
Conditions: Healthy Male Adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Nov 2017 (actual)
Primary completion: 18 Jan 2018 (actual)
Study completion: 18 Jan 2018 (actual)
First posted: 17 Nov 2017 (actual)
Results: Posted 3 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
ASC-01 in period 1, Aripiprazole and sertraline in period 2	Experimental	Drug: ASC-01, Drug: Aripiprazole and sertralineAt Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting.
Aripiprazole and sertraline in period 1, ASC-01 in period 2	Experimental	Drug: ASC-01, Drug: Aripiprazole and sertralineAt Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting.
Fasting in period 1, After breakfast in period 2	Experimental	Drug: ASC-01, Drug: Aripiprazole and sertralineAt Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast.
After breakfast in period 1, Fasting in period 2	Experimental	Drug: ASC-01, Drug: Aripiprazole and sertralineAt Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting.

Who may qualify

Ages: 20 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male subject at the age between 20 and 40 at the time of informed consent
Subject has a body mass index (BMI = body weight [kg]/height [m]2) of ≥18.5 and <25.0 kg/m2 at screening
Subject is providing consent for participation in this trial in writing prior to the start of the procedures related to this trial, and judged by the investigator or subinvestigator to be capable of observing procedures in this trial.

Key exclusion criteria (2 listed)

Subject has a clinically significant abnormality in physical findings at screening or in medical history that in the investigator's or subinvestigator's opinion may place the subject at risk or interfere with outcome variables including drug absorption, distribution, metabolism, and excretion.
Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ASC-01Aripiprazole 3 mg/sertraline 100 mg combination drug	Drug	ASC-01 in period 1, Aripiprazole and sertraline in period 2, After breakfast in period 1, Fasting in period 2, Aripiprazole and sertraline in period 1, ASC-01 in period 2, Fasting in period 1, After breakfast in period 2
Aripiprazole and sertralineAripiprazole 3 mg and sertraline 100 mg	Drug	ASC-01 in period 1, Aripiprazole and sertraline in period 2, After breakfast in period 1, Fasting in period 2, Aripiprazole and sertraline in period 1, ASC-01 in period 2, Fasting in period 1, After breakfast in period 2

Primary outcome

Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
Cmax of Aripiprazole and Sertraline in Cohort 2
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing
AUC168h of Aripiprazole and Sertraline in Cohort 2
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Results and safety

Results posted to the registry on 3 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: ASC-01 First	27	25
Cohort 1: Aripiprazole/Sertraline Concomitant First	27	25
Cohort 2: ASC-01 Under Fasted First	10	10
Cohort 2: ASC-01 Under Fed First	10	10

Primary outcome: Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1

Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing. Mean (Standard Deviation). Unit: ng/mL

Measure	ASC-01 n = 40	Aripiprazole/Sertraline Concomitant n = 39
Value	18.8 (5.33)	16.9 (4.38)

Population analysed: Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained.

Primary outcome: Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1

Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing. Mean (Standard Deviation). Unit: ng*h/mL

Measure	ASC-01 n = 40	Aripiprazole/Sertraline Concomitant n = 39
Value	783 (273)	779 (236)

Population analysed: Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained.

Primary outcome: Cmax of Aripiprazole and Sertraline in Cohort 2

Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing. Mean (Standard Deviation). Unit: ng/mL

Measure	ASC-01 Under Fasted n = 20	ASC-01 Under Fed n = 20
Aripiprazole	16.9 (5.23)	16.6 (3.74)
Sertraline	28.9 (10.7)	36.5 (15.6)

Population analysed: Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained.

Primary outcome: AUC168h of Aripiprazole and Sertraline in Cohort 2

Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing. Mean (Standard Deviation). Unit: ng*h/mL

Measure	ASC-01 Under Fasted n = 20	ASC-01 Under Fed n = 20
Aripiprazole	701 (221)	865 (219)
Sertraline	904 (415)	1060 (468)

Population analysed: Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained.

Adverse events

Time frame: Treatment-emergent adverse events occurring up to 8 days after dosing date were collected.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - ASC-01	0 of 52 (0%)	44 of 52 (84.6%)	0 of 52
Cohort 1 - Aripiprazole/Sertraline Concomitant	0 of 52 (0%)	43 of 52 (82.7%)	0 of 52
Cohort 2 - ASC-01 Under Fasted	0 of 20 (0%)	12 of 20 (60%)	0 of 20
Cohort 2 - ASC-01 Under Fed	0 of 20 (0%)	14 of 20 (70%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASC-01 and Aripiprazole and sertraline in people with Healthy Male Adults, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1 (time frame: Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03342963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.