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

NCT02113020 | Completed Phase 1

• 2 other identifiers: TAK-233/CPH-003U1111-1152-9381
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Clinical Pharmacology

Outcome Measures

Primary Outcomes (3)

• Change from baseline in motor threshold for urethral sphincter contraction.

  0.5 hours post-dose

• Change from baseline in motor threshold for urethral sphincter contraction.

  3 hours post-dose

• Change from baseline in motor threshold for urethral sphincter contraction.

  6 hours post-dose

Secondary Outcomes (1)

• Number of participants with adverse events

  Up to 28 days

Study Arms (2)

TAK-233

EXPERIMENTAL

Oral administration

Drug: TAK-233

Placebo

PLACEBO COMPARATOR

Oral administration

Drug: Placebo

Interventions

TAK-233 DRUG

Oral administration of TAK-233

TAK-233

Placebo DRUG

Oral admininstration of Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Study Officials

• General Manager

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: April 14, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

JP (1)