Food effect trial of voclosporin in healthy adult male subjects

Phase 1

• Conditions: upus nephritis

• Registration Number: JPRN-jRCT2071220014
• Lead Sponsor: Matsumaru Takehisa

Brief Summary

After single oral administration of 3 voclosporin soft gelatin capsules (7.9 mg/capsule; a dose of 23.7 mg as voclosporin) to healthy adult male subjects, the geometric mean ratio (90% confidence interval for geometric mean ratio) for Cmax, AUCinf, and AUCt in a fed versus fasting state was 0.9116 (0.7654-1.0857), 1.1434 (1.0218-1.2795), and 1.1364 (1.0172-1.2697), respectively. No notable safety issues were observed when voclosporin was administered either in a fasting state or in a fed state.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-10
• Study Completion: 2022-08-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 16

Inclusion 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified