Finding studies
Finding studies
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Lead
Takeda
The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the pharmacokinetics (PK), safety, and tolerability of TAK-279 in participants with severe (Part A) and moderate (Part B) renal impairment (RI) compared to healthy participants with normal renal function. The study will enroll up to 48 patients. Participants will be assigned to following study cohorts in Parts A and B to receive single-dose of TAK-279: * Cohort 1, Severe RI (12 participants): TAK-279 50 mg * Cohort 2, Normal Renal Function (12 to 24 participants): TAK-279 50 mg * Cohort 3, Moderate RI (12 participants): TAK-279 50 mg If the decision to proceed to Part B is made, participants with moderate RI will be enrolled in Cohort 3 of the study. Participants in Cohort 3 will receive single-dose of TAK-279 50 mg and will be compared with the participants who meet the matching criteria of Cohort 2 with normal renal function. A participant with normal renal function (either from Part A or enrolled in Part B) may be matched to only one participant with RI in Part B. This multi-center trial will be conducted in the United States. The overall duration of the study is up to 44 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
