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The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.
A Phase 1, Non-randomized, Open, Parallel-Group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child Pugh A | Experimental | CKD-501 will be administered to patients who are included Child Pugh A |
|
| Child Pugh B | Experimental | CKD-501 will be administered to patients who are included Child Pugh B |
|
| Subject who are matched Child Pugh A | Experimental | CKD-501 will be administered to the Subjects who are matched Child Pugh A |
|
| Subject who are matched Child Pugh B | Experimental | CKD-501 will be administered to the subjects who are matched Child Pugh B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-501 | Drug | CKD-501 0.5mg, PO(per oral), once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration(last) and Cmax of CKD-501 | Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 0 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite | Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 0 to 48 hours |
| Fraction Unbound of CKD-501 and its metabolite |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | up to 8 days | |
| Physical examination | up to 8 days | |
| Laboratory tests |
A. Inclusion Criteria
[The subjects with impaired hepatic function]
[The subjects with normal hepatic function]
B. exclusion criteria
[The subjects with impaired hepatic function]
[The subjects with normal hepatic function]
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| Name | Affiliation | Role |
|---|---|---|
| Min Soo Park, Ph.D. M.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Soeul | South Korea |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C546215 | lobeglitazone |
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|
sampling timepoint(hours)
: 1, 8
| 1 and 8 hours |
| Area Under the Concentration(last) and Cmax of the metabolite | sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | o to 48 hours |
| Metabolic ratio(metabolite/CKD-501) | sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 | 0 to 48 hours |
| up to 8 days |
| Adverse events | up to 8 days |