Clinical PharmacologyPhase 1NCT02113020
A Phase I Clinical Pharmacology Study of TAK-233 in Healthy Subjects
A Phase 1 study testing TAK-233 in people with Clinical Pharmacology, run by Takeda at 1 site in Japan.
Trial summary
The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- TAK-233
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Subjects who can sign the informed consent form and can date the form without assistance before starting the procedures of the clinical trial
- Healthy Japanese women
- Subjects aged ≥ 20 and ≤ 40 years at the time of consent
- Subjects with body weight ≥ 45 kg and BMI ≥18.5 and ≤ 25.0 kg/m2 at the time of screening
- 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
Who cannot join
- Subjects who received TAK-233 within 16 weeks before the start of initial administration
- Subjects who have previously received TAK-233 during treatment or during participation in another clinical trial
- 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
- 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
- Subjects with hypersensitivity to TAK-233 related substances, or excipients of these products
- Subjects whose urine tested positive for drug abuse at screening
Show all 23Show fewer
- 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
- Subjects who need to take prohibited concomitant medications, vitamins, or foods listed in listed in what?
- 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
- 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)
- 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
- Subjects with a history of cancer (excluding subjects whose basal cell carcinoma has been in remission for at least 5 years
- 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
- Subjects who took nicotine-containing products (e.g., cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 28 days before hospitalization
- Subjects for whom blood collection from peripheral veins is difficult
- 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
- Subjects who donated at least 400 mL (in total) of whole blood within 52 weeks before the start of the initial administration
- Subjects who donated blood components within 2 weeks before the start of the initial administration
- Subjects with clinically significant abnormalities on the electrocardiogram recorded at screening or hospitalization (Day -1 of the first treatment period)
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Clinical Pharmacology
- Being tested
- TAK-233, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-233Drug
Oral administration of TAK-233
PlaceboDrug
Oral admininstration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| TAK-233 | Experimental | Oral administration Receives: Drug: TAK-233 |
| Placebo | Placebo comparator | Oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in motor threshold for urethral sphincter contraction.
Measured: 0.5 hours post-dose
Change from baseline in motor threshold for urethral sphincter contraction.
Measured: 3 hours post-dose
Change from baseline in motor threshold for urethral sphincter contraction.
Measured: 6 hours post-dose
Secondary outcomes (1)
Number of participants with adverse events
Treatment emergent adverse events, vital signs, weight, safety ECG, and clinical laboratory tests (hematology, serum chemistry, and urinalysis).
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113020
- Sponsor's protocol ID
- TAK-233/CPH-003
- Other IDs
- U1111-1152-9381
- Status last verified
- Oct 2014
- First submitted
- 21 Feb 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02113020
- Acronym / sponsor ID
- TAK-233/CPH-003
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-233 | Experimental | Drug: TAK-233Oral administration |
| Placebo | Placebo comparator | Drug: PlaceboOral administration |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Subjects who can sign the informed consent form and can date the form without assistance before starting the procedures of the clinical trial
- Healthy Japanese women
- Subjects aged ≥ 20 and ≤ 40 years at the time of consent
- Subjects with body weight ≥ 45 kg and BMI ≥18.5 and ≤ 25.0 kg/m2 at the time of screening
Key exclusion criteria (23 listed)
- Subjects who received TAK-233 within 16 weeks before the start of initial administration
- Subjects who have previously received TAK-233 during treatment or during participation in another clinical trial
- 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
- 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
- Subjects with hypersensitivity to TAK-233 related substances, or excipients of these products
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 |
|---|---|---|
| TAK-233Oral administration of TAK-233 | Drug | TAK-233 |
| PlaceboOral admininstration of Placebo | Drug | Placebo |
Primary outcome
Change from baseline in motor threshold for urethral sphincter contraction.
Time frame: 0.5 hours post-dose
Change from baseline in motor threshold for urethral sphincter contraction.
Time frame: 3 hours post-dose
Change from baseline in motor threshold for urethral sphincter contraction.
Time frame: 6 hours post-dose
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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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.
General Manager study director
Takeda
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 TAK-233 in people with Clinical Pharmacology, run by Takeda 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 6 inclusion and 23 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 21 Oct 2014. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in motor threshold for urethral sphincter contraction. (time frame: 0.5 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2014.