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Completed

NCT Number: NCT00585143

Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

Completed

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Key information

Conditions

Dyslipidemia, Renal Insufficiency Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 6610, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-335

Drug

45 mg once daily for 10 consecutive days

Rosuvastatin

Drug

10 mg once daily for 10 days

Primary outcomes

  1. Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin

    Time frame: Days 1, 8, 9, and 10

Secondary outcomes

  1. Safety and tolerability of the study drugs

    Time frame: Study duration

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 3, 2008
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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