Who is sponsoring NCT04118127?

NCT04118127 is sponsored by Otsuka Pharmaceutical Co., Ltd..

What drugs are being tested in NCT04118127?

Interventions in NCT04118127: 2mg conventional tablet, once-weekly tablets.

What condition does NCT04118127 study?

NCT04118127 studies Schizophrenia.

Is NCT04118127 still recruiting?

NCT04118127 is currently completed. Last updated 5 August 2024.

Are results published for NCT04118127?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-05 · How we verify

NCT04118127

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses

Completed Phase 1 Results posted Last updated 5 August 2024

What this trial tests

Phase 1 trial testing 2mg conventional tablet, once-weekly tablets in Schizophrenia in 73 participants. Completed in 3 March 2021.

Timeline

17 October 2019

Primary endpoint
16 February 2021

3 March 2021

Quick facts

Lead sponsor	Otsuka Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	17 October 2019
Primary completion	16 February 2021
Estimated completion	3 March 2021
Sites	1 location across Japan

Drugs / interventions tested

2mg conventional tablet, once-weekly tablets — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Otsuka Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 64, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1 Primary · prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose

To evaluate Cmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .

Group	Value	95% CI
Conventional Tablet 2mg	25.37	± 10.46
QW Formuration 24mg	98.62	± 46.76
QW Formuration 48mg	222.3	± 114.3

Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1 Primary · prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose

To evaluate Tmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .

Group	Value	95% CI
Conventional Tablet 2mg	4.00	1.75 – 24.37
QW Formuration 24mg	25.37	8.75 – 49.50
QW Formuration 48mg	25.00	8.60 – 46.42

Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2 Primary · prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose

To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.

Group	Value	95% CI
QW Formuration 48mg	225.0	± 147.7

Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2 Primary · prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose

To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.

Group	Value	95% CI
QW Formuration 48mg	24.61	8.50 – 49.25

Adverse events — posted to ClinicalTrials.gov

Time frame: From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 Period 2

Serious: 0/34 (0%)

Deaths: 0/34

Cohort 1 Period 3

Serious: 1/23 (4%)

Deaths: 0/23

Cohort 2 Period 2

Serious: 0/34 (0%)

Deaths: 0/34

Cohort 1 Period 1

Serious: 0/38 (0%)

Deaths: 0/38

Cohort 2 Period 1

Serious: 0/35 (0%)

Deaths: 0/35

Serious adverse events (1 terms)

Reaction	System	Cohort 1 Period 2	Cohort 1 Period 3	Cohort 2 Period 2	Cohort 1 Period 1	Cohort 2 Period 1
Schizophrenia	Psychiatric disorders	—	—	—	—	—

Other adverse events (101 terms — click to expand)

Reaction	System	Cohort 1 Period 2	Cohort 1 Period 3	Cohort 2 Period 2	Cohort 1 Period 1	Cohort 2 Period 1
Headache	Nervous system disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—	—
Akathisia	Nervous system disorders	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Blood Creatine Phosphokinase Increased	Investigations	—	—	—	—	—
Blood Insulin Increased	Investigations	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Extrapyramidal Disorder	Nervous system disorders	—	—	—	—	—
Sedation	Nervous system disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Abdominal Discomfort	Gastrointestinal disorders	—	—	—	—	—
Iron Deficiency Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Atrioventricular Block First Degree	Cardiac disorders	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—
Hyperprolactinaemia	Endocrine disorders	—	—	—	—	—
Dry Eye	Eye disorders	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—	—
Dental Caries	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—
Thirst	General disorders	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—
Infected Dermal Cyst	Infections and infestations	—	—	—	—	—
Oral Herpes	Infections and infestations	—	—	—	—	—
Skin Infection	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Ligament Sprain	Injury, poisoning and procedural complications	—	—	—	—	—
Skin Abrasion	Injury, poisoning and procedural complications	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—
Blood Bilirubin Increased	Investigations	—	—	—	—	—

Most-reported serious reactions: Schizophrenia.

Data from ClinicalTrials.gov NCT04118127 adverse events section.

Sponsor's own description

To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Otsuka Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07053891 — LUPKYNIS Drug-use Results Survey · recruiting
NCT06875986 — REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapi · recruiting
NCT06036108 — Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia · Phase 1 · completed
NCT05712746 — Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure. · recruiting
NCT05687071 — A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04118127 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd.
Last refreshed: 5 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04118127.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing