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Trial record 49 of 64 for:    brexpiprazole

Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02875080
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).

Condition or disease Intervention/treatment Phase
Healthy Adult Male Drug: OPC-34712 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : November 27, 2016
Actual Study Completion Date : November 27, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OPC-34712 disintegrating tablet with water
OPC-34712 (4 mg) orally disintegrating tablet is administered with water.
Drug: OPC-34712
Other Name: Brexpiprazole

Experimental: OPC-34712 disintegrating tablet without water
OPC-34712 (4 mg) orally disintegrating tablet is administered without water.
Drug: OPC-34712
Other Name: Brexpiprazole

Experimental: OPC-34712 conventional tablet with water
OPC-34712 (4 mg) conventional tablet is administered with water.
Drug: OPC-34712
Other Name: Brexpiprazole




Primary Outcome Measures :
  1. Cmax of OPC-34712 [ Time Frame: Pre pose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose ]
    To evaluate Cmax of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation

  2. AUC of OPC-34712 [ Time Frame: Pre pose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose ]
    To evaluate AUC of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

  • Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
  • History of serious mental disorder
  • History of drug or alcohol abuse within 2 years prior to screening
  • History of any significant drug allergy
  • Use of an investigational drug within 120 days prior to the first dosing of trial drug
  • Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
  • Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
  • Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
  • History of major surgery of the digestive tract (excluding appendectomy)
  • Any subject who, in the opinion of the investigator, should not participate in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875080


Locations
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Japan
Kyusyu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02875080     History of Changes
Other Study ID Numbers: 331-102-00019
JapicCTI-163351 ( Other Identifier: Japic )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents