Renal Impairment Clinical Trial
Official title:
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of 100 mg Multiple Doses of GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects
This will be an open label study to assess the influence of renal impairment on the
pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations
of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy
controls.
Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects
with renal impairment and matched healthy controls will be evaluated.
The study will be divided in two parts.
In Part 1, 3 subjects with severe renal impairment or end-stage renal disease (ESRD) not yet
requiring dialysis (Group 1) will be recruited first. Thereafter, 3 subjects with normal
renal function (Group 2) will be recruited. If a substantial effect on the PK in renal
impaired subjects is observed on Day 10, the sponsor may elect to stop Part 1 of the study
without enrolling the complete set of subjects and Part 2 will be initiated. In case no
substantial effect on the PK is observed, 3 further subjects in both Group 1 and 2 will be
recruited and analysed. If a substantial effect on the PK is observed, the study will
proceed to Part 2. Part 2 of the study will not be conducted, if in Part 1 no substantial
difference in PK is seen.
In Part 2, Group 3 (mild renal impairment) and Group 4 (moderate renal impairment) will be
recruited first. After completion of the mild and moderate impairment groups, Group 5
(normal renal function) will be recruited.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01937975 -
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
|
Phase 1 | |
| Completed |
NCT03284164 -
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
|
Phase 1 | |
| Completed |
NCT05992155 -
A Study of TAK-279 in Adults With or Without Kidney Problems
|
Phase 1 | |
| Completed |
NCT05004311 -
The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT04963738 -
A Study of JNJ-73763989 in Adult Participants With Renal Impairment
|
Phase 1 | |
| Terminated |
NCT02508740 -
Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment
|
Phase 1 | |
| Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
| Terminated |
NCT00984113 -
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
|
Phase 1 | |
| Completed |
NCT00842868 -
The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases
|
N/A | |
| Completed |
NCT00750620 -
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
|
Phase 1 | |
| Completed |
NCT00499187 -
Fanconi Syndrome Due to ARVs in HIV-Infected Persons
|
Phase 4 | |
| Completed |
NCT01331941 -
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
|
Phase 1 | |
| Completed |
NCT05489614 -
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment
|
Phase 1 | |
| Completed |
NCT03259087 -
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
|
Phase 1 | |
| Completed |
NCT05086107 -
Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
|
Phase 1 | |
| Recruiting |
NCT05349851 -
Bowel Cleansing With Renal Impairment
|
||
| Completed |
NCT03660241 -
A Renal Impairment Study for PF-04965842
|
Phase 1 | |
| Recruiting |
NCT06037031 -
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
|
Phase 1 | |
| Completed |
NCT03289208 -
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
|
Phase 1 | |
| Completed |
NCT02942810 -
To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
|
Phase 1 |