Lupus nephritis
Conditions
Interventions
Voclosporin 23.7 mg (three 7.9-mg soft gelatin capsules) will be administered as a single oral dose in a fasting state or within 10 minutes after the ingestion of a high-fat meal consumed over 20 minu
Sponsors
Matsumaru Takehisa
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Japanese males aged >= 20 to =18.5 kg/m2 to < 25.0 kg/m2 (at screening) 3)Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the investigator or subinvestigator, to comply with all the requirements of the trial
Exclusion criteria
Exclusion criteria: 1)Any clinically significant abnormality (eg, significant deviation from the normal range) found on history or on a screening examination that, in the opinion of the investigator, subinvestigator, or sponsor, may jeopardize subject safety or affect any endpoint such as drug absorption, distribution, metabolism, or excretion. Relevant abnormalities include, but are not limited to, a history of or current cardiac, hepatic, renal, neurological, gastrointestinal, respiratory, hematological, or immunological diseases. 2)Clinically significant 12-lead ECG finding,such as atrioventricular block, QRS interval > 120 msec, QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >= 450 msec (at screening) 3)For hepatitis, the subject meets any of the following: -The subject has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (including the subject testing positive for hepatitis B surface antigen [HBsAg], HBV antibody [HBs, HBc], or HCV antibody at screening, except for the subject testing positive for HBs antibody after hepatitis B vaccination). -The subject has a history of or currently has alcoholic hepatitis or nonalcoholic steatohepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in natural log transformation between meal conditions and its 90% confidence interval for Cmax, AUCinf, and AUCt of whole blood voclosporin in a fed versus fasting state | — |
Contacts
Public ContactInformation Center Drug
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed