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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00681525
First received: May 19, 2008
Last updated: October 18, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics
Drug: ABT-335
Drug: Atorvastatin
Drug: Ezetimibe
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • PK interaction [ Time Frame: Study duration approximately 62 days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: April 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ABT-335 135 mg
Drug: ABT-335
One ABT-335 135 mg capsule QD for 10 days
Other Names:
  • fenofibric acid
  • ABT-335
Experimental: B
Atorvastatin 80 mg and Ezetimibe 10 mg
Drug: Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
Other Name: atovastatin
Drug: Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days
Other Name: ezetimibe
Experimental: C
ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg
Drug: ABT-335
One ABT-335 135 mg capsule QD for 10 days
Other Names:
  • fenofibric acid
  • ABT-335
Drug: Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
Other Name: atovastatin
Drug: Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days
Other Name: ezetimibe

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681525

Locations
United States, Florida
Site Reference ID/Investigator# 8087
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00681525     History of Changes
Other Study ID Numbers: M10-367
Study First Received: May 19, 2008
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fenofibric acid
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014