Food effect trial of voclosporin in healthy adult male subjects

JRCT ID: jRCT2071220014

Registered date:10/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lupus nephritis
• Date of first enrollment: 06/07/2022
• Target sample size: 16
• Study type: Interventional
• Intervention(s): 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 minutes or less.

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1)Japanese males aged >= 20 to < 40 years
2)Body mass index (BMI) = Body weight (kg) / [Height (m)]2: >=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

Exclude 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.

Related Information

• Primary Sponsor: Matsumaru Takehisa