Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-335 | Drug | 45 mg once daily for 10 consecutive days |
| |
| Rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin | Days 1, 8, 9, and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the study drugs | Study duration |
Not provided
Inclusion Criteria
Body Mass Index (BMI) 19 to 33, inclusive
Either normal kidney function, or mild or moderate kidney impairment
Exclusion Criteria
Use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management of renal disease.
History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Torbjörn Lundström, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 6610 | Gainesville | Florida | 32608 | United States | ||
| Site Reference ID/Investigator# 6738 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
10 mg once daily for 10 days |
|
| Miami |
| Florida |
| 33136 |
| United States |
| Site Reference ID/Investigator# 7723 | Minneapolis | Minnesota | 55404 | United States |
| Site Reference ID/Investigator# 7319 | Knoxville | Tennessee | 37920 | United States |
| Site Reference ID/Investigator# 6928 | San Antonio | Texas | 78209 | United States |
| Site Reference ID/Investigator# 8280 | Richmond | Virginia | 23298-0160 | United States |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533234 | 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided