A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
NCT06295796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-02-17
Summary
The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.
Conditions
- Renal Impairment
Interventions
- DRUG
-
MK-8527
Oral Capsule
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-20
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Single Dose Study of MK-8266 (MK-8266-001)
NCT01025791 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
NCT05624710 ·Status: COMPLETED ·Phase: PHASE1
-
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
NCT01240967 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) 80/20/10mg
NCT04987970 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
NCT01767688 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment
NCT05916573 ·Status: COMPLETED ·Phase: PHASE1
-
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
NCT05093972 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction
NCT06383897 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
NCT03295266 ·Status: TERMINATED ·Phase: PHASE1
-
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
NCT02474537 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.
NCT04831996 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
NCT02975388 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With Impaired Renal Function
NCT06657560 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
NCT02059590 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
NCT05812417 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
NCT06576765 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
NCT01626651 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate ACT-132577 in Healthy Subjects and in People With Severe Kidney Disease
NCT03165071 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)
NCT04676425 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2)
NCT04694989 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of MK-8266 in Elderly Participants With High Blood Pressure (MK-8266-003)
NCT01263314 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
NCT04476849 ·Status: COMPLETED ·Phase: PHASE1
-
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
NCT02039817 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions
NCT05552495 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment
NCT04469907 ·Status: COMPLETED ·Phase: PHASE1