A Phase I Clinical Pharmacology Study of TAK-233 in Healthy Subjects

October 20, 2014 updated by: Takeda

A Randomized, Double-blind, Single-dose, 4 × 4 Crossover Phase I Study to Examine the Effects of TAK-233 on the Urethral Function in Healthy Female Subjects

The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this study is to examine the pharmacodynamics and the safety of TAK-233 administered as a single dose in healthy women.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects who understand the contents of this clinical trial and who the investigator or sub-investigator consider able to comply with the procedures of the clinical trial
  2. Subjects who can sign the informed consent form and can date the form without assistance before starting the procedures of the clinical trial
  3. Healthy Japanese women
  4. Subjects aged ≥ 20 and ≤ 40 years at the time of consent
  5. Subjects with body weight ≥ 45 kg and BMI ≥18.5 and ≤ 25.0 kg/m2 at the time of screening
  6. Women of child bearing potential who agree to take specified contraceptive measures regularly from the time of consent until 4 weeks after the end of the last assessment in the fourth treatment period

Exclusion Criteria:

  1. Subjects who received TAK-233 within 16 weeks before the start of initial administration
  2. Subjects who have previously received TAK-233 during treatment or during participation in another clinical trial
  3. Employees of the medical institution conducting this clinical trial and their family/dependents (e.g., husband or wife, parents, children, and siblings), or subjects who may be coerced to agree to participate in the clinical trial
  4. Subjects with poorly controlled and clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (including chronic costiveness), urological (including dysuria), autoimmune, endocrine, or psychiatric diseases or other abnormalities which may affect the subject's participation in the clinical trial or results of the clinical trial
  5. Subjects with hypersensitivity to TAK-233 related substances, or excipients of these products
  6. Subjects whose urine tested positive for drug abuse at screening
  7. Subjects with a history of drug abuse (defined as the use of illegal drugs) or alcohol dependence within 52 weeks before the screening assessments, or subjects who are not willing to stop alcohol intake or drug use during their participation in the clinical trial
  8. Subjects who need to take prohibited concomitant medications, vitamins, or foods listed in listed in what?
  9. Pregnant or lactating women, women expecting to be pregnant before giving consent, during this clinical trial, or within 4 weeks after the completion of this clinical trial, or women who are planning to donate their ova during this period
  10. Subjects with currently active cardiovascular diseases, central nervous system diseases, hepatic diseases, hematopoietic diseases, renal failure, metabolic disorders, endocrine disorders, serious allergies, asthma, hypoxemia, hypertension, convulsion, allergic exanthema, or urological disorders (subjects with peptic ulcer, convulsive disorders, or arrhythmia also fall this category)
  11. Subjects that have any of the following diseases/surgical interventions that may affect drug absorption: digestive system disorders (malabsorption, esophageal reflux, peptic ulcer, erosive oesophagitis, frequent heartburn (at least once a week), or surgical interventions (e.g., cholecystectomy), or subjects who have had prior history of any of these diseases/surgical interventions within the last 24 weeks
  12. Subjects with a history of cancer (excluding subjects whose basal cell carcinoma has been in remission for at least 5 years
  13. Subjects that have tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, or syphilis serological reaction at screening
  14. Subjects who took nicotine-containing products (e.g., cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 28 days before hospitalization
  15. Subjects for whom blood collection from peripheral veins is difficult
  16. Subjects who donated at least 200 mL of whole blood within 4 weeks before the start of the initial administration, or subjects who donated at least 400 mL of whole blood within 16 weeks before the start of the initial administration
  17. Subjects who donated at least 400 mL (in total) of whole blood within 52 weeks before the start of the initial administration
  18. Subjects who donated blood components within 2 weeks before the start of the initial administration
  19. Subjects with clinically significant abnormalities on the electrocardiogram recorded at screening or hospitalization (Day -1 of the first treatment period)
  20. Subjects who had a QTcF interval of > 470 msec or a PR interval of < 120 msec or > 220 msec on the electrocardiogram recorded at screening or hospitalization
  21. Subjects with a systolic blood pressure of < 100 mmHg or > 140 mmHg and a diastolic blood pressure of < 60 mmHg or > 90 mmHg at screening or hospitalization
  22. Subjects with a heart rate of < 50 bpm or > 90 bpm at screening or hospitalization

22. Subjects unlikely to comply with the protocol, or subjects the investigator or sub-investigator considers ineligible for participation in the clinical trial due to other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Oral administration
Drug: Placebo
Oral admininstration of Placebo
Experimental: TAK-233
Oral administration
Drug: TAK-233
Oral administration of TAK-233

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in motor threshold for urethral sphincter contraction.
Time Frame: 0.5 hours post-dose
0.5 hours post-dose
Change from baseline in motor threshold for urethral sphincter contraction.
Time Frame: 3 hours post-dose
3 hours post-dose
Change from baseline in motor threshold for urethral sphincter contraction.
Time Frame: 6 hours post-dose
6 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to 28 days
Treatment emergent adverse events, vital signs, weight, safety ECG, and clinical laboratory tests (hematology, serum chemistry, and urinalysis).
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-233/CPH-003
  • U1111-1152-9381 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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