Healthy adults
Conditions
Interventions
SJP-0008 is single orally administrated.
Placebo is single orally administrated.
SJP-0008 is single orally administrated both under fasting and fed conditions.
Placebo is single orally administrated b
Sponsors
Senju Pharmaceutical co.,ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Signature of the subject on the Informed Consent Form. 2) Male subject who is from 20 to35 year of age.
Exclusion criteria
Exclusion criteria: 1) History of serious disease (e.g.: eye, liver, kidney, cardiac, digestive or blood disease) 2) Subjects with cardiac disease including cardiac failure and ischemic heart disease. 3) Subjects with QTc interval of 450 ms or greater. 4) Subjects with notable respiratory arrhythmia, frequent premature beat or branch block. 5) Subjects with abnormal of serum electrolyte levels. 6) Subjects with eGFR of under 60 mL/min/1.73 m^2. 7) Subjects with exceed reference level of AST or ALT. 8) History of drug allergy. 9) Use of any drugs (including over the counter drugs) within past 2 week. 10) Subjects with donation of blood more than 400 mL within past 3 months. 11) Participation in any other clinical study within past 4 months. 12) History of keratorefractive surgery or traumatic injury of any eyes. 13) Willing to use contact lens during the study. 14) Subject with best-corrected visual acuity equal to or less than 1.0. 15) Subject with BMI less than 18.5 or more than 25.0. 16) Subjects do not agree with contraception or correspondence to partner's pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation (Clinical examination, Vital sign, Ophthalmic examination, Laboratory test, Adverse event) and Pharmacokinetics of SJP-0008 | — |
Countries
Japan
Contacts
Public ContactTetsuo Kida
Senju Pharmaceutical co.,ltd. Regulatory Affairs & Medical Writing, Clinical Development
Outcome results
None listed