NCT05992155

A Study of TAK-279 in Adults With or Without Kidney Problems

An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with kidney problems compared to participants without kidney problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. The participants will need to stay at the clinic for 11 days.

Detailed description

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.

Conditions

• Renal Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-279	TAK-279 capsules.

Timeline

• Start date: 2023-09-27
• Primary completion: 2024-05-22
• Completion: 2024-05-28
• First posted: 2023-08-15
• Last updated: 2024-06-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study