Healthy male volunteers
Conditions
Interventions
investigational material(s)
Generic name etc : CS-4771
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigatio
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - male Japanese - between the age of 20 and 45 - between the BMI of 18.5 and 25.0
Exclusion criteria
Exclusion criteria: - A history of serious diseases caused by disorders of the central nervous system, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, hepatic and renal function, thyroid function, pituitary gland function, adrenal function, etc., and the judgment of the investigator or subinvestigator that participation in the clinical study could pose a risk to the subject's safety - MetHB level of 2% or greater, or MetHB value of 0.24 g/dL or greater - Hypersensitivity to methylene blue or Toll-like receptor 4 (TLR4) inhibitors - Inappropriateness for inclusion into the study as judged by the investigator or subinvestigator (for example, subjects who may have difficulty in visiting the study center or ensuring compliance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Pharmacodynamic and Pharmacokinetic | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety endpoints according to the adverse events, vital signs, 12-lead ECGs and laboratory values. To evaluate pharmacodynamic endpoints according to the release of TNF-a and IL-6 when whole blood is stimulated ex vivo using LPS. To evaluate pharmacokinetic endpoints according to the free form of CS 4771 in plasma. | — |
Outcome results
None listed