Last updated on June 2017

Safety Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis


Brief description of study

The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.

Detailed Study Description

The drug being tested in this study is called ixazomib. Ixazomib is being tested to find a safe and well tolerated dose in participants with lupus nephritis. This study will look at side effects and lab results in participants who take ixazomib, along with the determination of the pharmacokinetics (PK). This study is designed as a randomized, sequential-panel, multiple rising dose study. The study will enroll approximately 40 participants. The study population will consist of 4 Cohorts. At least 5 participants (4:1) will be recruited into the 0.5 mg dose group (Cohort A), at least 5 participants (4:1) in the 2.0 mg dose group (Cohort B), 8 participants (6:2) in the 3.0 mg dose group (Cohort C), and 8 participants (6:2) in the 4.0 mg dose group (Cohort D). Participants in each Cohort will be asked to take one capsule on Days 1, 8 and 15 in a 28-days cycle, for 3 cycles. PK samples will be collected Predose on Days 1, 8 and 15. Cycle 1 - Postdose Day 1 at 0.25, 0.5, 1, 1.5, 2, 4, 8, 24, and 168 hours. Cycle 2 - Postdose Day 15 at 168 hours. Cycle 3 - Postdose on Day 15 following the third dose, samples will be collected at 0.25, 0.5, 1, 1.5, 2, 4, 8, 24, 168 and 312 hours . The starting dose in Cohort 1 will be 0.5 mg followed by administrations of 2, 3 and 4 mg in subsequent cohorts. This multi-center trial will be conducted in the United States and Europe. The overall time to participate in this study is up to 196 days. Participants will make 19 visits to the clinic during the treatment period and will make follow-up visits monthly for 3 months for follow-up assessments.

Clinical Study Identifier: NCT02176486

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