TBD
Conditions
Interventions
1) Single agent administration Part
Subjects receive single oral dose of ONO-7018 or placebo.
2) Concomitant administration part
Subjects receive single oral dose of ONO-7018 with or without itracon
Sponsors
Hirashima Yoshinori
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese healthy adult male subjects 2) Age at the time of informed consent: 18 to 45 3) BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2
Exclusion criteria
Exclusion criteria: 1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease. 2) Subjects with current or with a history of severe allergy to drugs or foods 3) Subjects with current or with a history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse events that occurred after administration of ONO-7018 until the end of final examination -Summary Statistics of Plasma ONO-7018 Concentrations and Pharmacokinetic Parameters -Geometric mean ratios and 90% confidence intervals of Cmax and AUC of ONO-7018 in the concomitant use with itraconazole to those in the administration of ONO-7018 alone | — |
Contacts
Public ContactCenter Medical
Ono Pharmaceutical Co.,LTD
Outcome results
None listed