A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: ABT-335; Drug: Atorvastatin; Drug: Ezetimibe

• Registration Number: NCT00681525
• Lead Sponsor: Abbott

Brief Summary

The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2008-06
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-18
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy male or female subjects

Exclusion Criteria

• Clinically significant diseases or disorders
• Positive screens for drug and alcohol
• Pregnant or breast-feeding females
• Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	ABT-335	ABT-335 135 mg
C	ABT-335	ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg
B	Atorvastatin	Atorvastatin 80 mg and Ezetimibe 10 mg
B	Ezetimibe	Atorvastatin 80 mg and Ezetimibe 10 mg
C	Atorvastatin	ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg
C	Ezetimibe	ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg

Primary Outcome Measures

Name	Time	Method
PK interaction	Study duration approximately 62 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 8087; 🇺🇸 Gainesville, Florida, United States