Idiopathic triglyceride deposit cardiomyovasculopathy
Conditions
Interventions
Sequential single oral escalating doses of CNT-01(250mg, 500mg and 2000mg) under fasting condition followed by CNT-01 500mg under fed condition
Sponsors
Oita University
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gave written informed consent after receiving a sufficient explanation upon participation in the study 2) Between the ages of 20 and 65 at the time of obtaining informed consent 3) Body weight more than 45 kg, height taller than 140 cm and Body Mass Index (BMI) between 17.5 kg/m2 and 30.0 kg/m2 at screening 4) Are able to abstain from smoking throughout the duration of the study 5) Are able to follow the protocol, undergo consultation/examination as described in the protocol and report their symptoms 6) Underwent screening tests within one month before investigational product (IP) administration and judged eligible by the investigator
Exclusion criteria
Exclusion criteria: 1) Have a medically significant complication such as digestive, renal, respiratory, endocrine, hematologic, nervous, psychiatric and cardiovascular disorder and inborn errors of metabolism 2) Had an acute disease within 2 weeks before IP administration (e.g., stomachache, nausea, vomiting, anorexia, fever) 3) Took a prescription drug, over the counter drug, nutrient, vitamin or herbal preparation (including Chinese medicine) within 2 weeks before IP administration 4) Have a present condition or known history of drug or food allergy 5) Participated or are currently participating in another clinical study or post-marketing clinical trial within 3 months before IP administration 6)Ingested any medicine, food or beverage (e.g., coffee, tea, chocolate, coke) containing methylxanthine such as caffeine within 48 hours before IP administration 7)Subjects with or suspected of alcohol or drug abuse at screening 8)Ingested any food or beverage containing grapefruit juice, grapefruit, St. Johns wort or Seville orange within 72 hours before IP administration 9) Fall under any of the following -received blood transfusion within 3 months before IP administration -donated whole blood more than or equal to 400 mL within 3 months before IP administration -donated whole blood more than or equal to 200 mL within a month before IP administration -donated blood component within 2 weeks before IP administration 10) Had an infection requiring treatment within a month before IP administration 11) Diagnosed with AIDS or HIV positive 12) Positive for HBs antigen, HCV antibody or syphilis serology test 13) Have eGFR less than 60.0 mL/min/1.73 m2 at screening 14) Women who are or may be pregnant, who are unable to practice contraception properly (e.g., avoiding sexual intercourse, using an intrauterine device) within 12 weeks after IP administration or who are lactating 15) Employed by the CRO related to the study or the medical institution 16) Considered unfit for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC0-inf) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Maximum plasma concentration (Cmax) - Time to maximum plasma concentration (tmax) - Elimination half-life (t1/2) - Area under the plasma concentration-time curve (AUClast) - Change in plasma concentration - Linearity of AUC0-inf vs. dose - Safety (Adverse events, adverse drug reactions and laboratory tests) | — |
Countries
Japan
Contacts
Public ContactNaoto Uemura
Oita University Hospital Clinical Pharmacology Center
Outcome results
None listed