Interstitial Cystitis/Bladder Pain Syndrome
Conditions
Interventions
In accordance with the randomly assigned treatment sequence, a single oral dose of JTE-051, placebo, or Moxifloxacin will be administered in the fasted state.
Sponsors
Mitsui Hironori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy Japanese males and females aged 18 to 45 years (inclusive) at the time of obtaining informed consent (2)BMI of >=18.5 and =90 and =40 and =50 and <100 beats/min 2) 12-lead ECG at rest -QTcF interval: <450 ms -QRS duration: <110 ms -PR interval: <210 ms (4)Participants who have given written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: (1)Participants who have a serious medical history of, or are currently under treatment for the brain, liver, kidneys, lungs, gastrointestinal system, hematologic system, endocrine system, metabolic system, psychiatric system, or other systems (2)Participants meeting any of the following criteria according to the result of screening test*1 performed at the Screening Visit 1) Participants who do not receive negative test results in the immunological test (HBs antigen, HCV antibody, serological test for syphilis [TP antibody method, RPR method], HIV antigen/antibody) or urine drugs of abuse screen 2) Participants who are ineligible for study participation in the opinion of the investigator or subinvestigator*2 *1: Re-testing of laboratory test parameters at the Screening Visit will not be performed in principle. However, if the reason is judged to be appropriate, re-testing will be performed, and the eligibility will be judged using the results. *2: If there is any deviation from the reference values of any laboratory test item at the Screening Visit, the investigator or subinvestigator will comprehensively judge the participant's eligibility to participate in the study from a medical viewpoint, also considering the results of other screening tests. (3)Participants who are determined by the investigator or subinvestigator that any clinically important abnormalities in the 12-lead ECG at the Screening Visit or on the day of Period 1 admission may interfere with the interpretation of changes in the QTc interval (4)Participants with a history of or current arrhythmia or clinically significant cardiac disease, or a history of risk factors for Torsades de Pointes (family history of sudden death, unexplained syncope, heart failure, hypokalemia, family history of long QT syndrome) (5)Participants with a history of gastrointestinal surgery that could interfere with drug absorption (6)Participants with a history of or current severe allergy for drug or food (7)Participants with a history of drug hypersensitivities for quinolone class of antibiotics including Moxifloxacin (8)Participants with a history of or current drug or alcohol dependence (9)Participants who have used drugs (excluding ophthalmic drugs other than antibacterial ophthalmic solutions and other drugs considered by the investigator or subinvestigator not to affect the study) within 1 week before the day of Period 1 admission (10)Participants who have used any drugs that prolong the QT/QTc interval (e.g., erythromycin, antipsychotics and tricyclic antidepressants) within 2 weeks before the day of Period 1 admission (11)Participants who have smoked or used nicotine-containing products (e.g., cigar, nicotine patch) within 4 weeks before the day of Period 1 admission (12)Participants who have been treated with any investigational products, study drugs, or procedures within 16 weeks or 5 times the half-life (whichever is longer) before the day of Period 1 admission in another clinical study including that of a medical device or a clinical trial that may affect this study (13)Participants who have undergone blood collection of more than 400 mL within 12 weeks (within 16 weeks for female participants) or more than 200 mL within 4 weeks before the day of Period 1 admission (except for the blood collection for this study in either case), or who donated blood components within 2 weeks before the day of Period 1 admission (14)Male participants who have not consented to abstain from sexual inter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of central tendency of QTcF (Fridericia corrected QT interval) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) ECG 1) Categorical analysis of QTcF 2) Other ECG parameters (heart rate, RR interval, PR interval, QRS duration, QT interval) 3) ECG waveforms (T-wave morphology, presence of U-wave) 4) Relationship between QT/QTc interval changes and plasma concentration of JTE-051 (2) Pharmacokinetics (3) Safety | — |
Contacts
Public Contactinformation clinical trials
Shionogi & Co.,Ltd.
Outcome results
None listed