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

NCT03342963 | Completed Phase 1 Results

• 2 other identifiers: 031-102-00214JapicCTI-173774
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (4)

• Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1

  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

  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

  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

  Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing

Study Arms (4)

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.

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.

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.

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.

Drug: ASC-01; Drug: Aripiprazole and sertraline

Interventions

ASC-01 DRUG

Aripiprazole 3 mg/sertraline 100 mg combination 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 sertraline DRUG

Aripiprazole 3 mg and sertraline 100 mg

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Clinic of Kyusyu Region

Fukuoka, Japan

Location

MeSH Terms

Interventions

Aripiprazole; Sertraline

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 17, 2017
• Study Start: November 21, 2017
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)