A Multiple-Dose Pharmacokinetic Interaction Study Between... | NCT00681525

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

NCT00681525

Sponsor

Abbott

Status

Completed

Last Update Posted

Oct 19, 2010Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Pharmacokinetics

Interventions

ABT-335
Atorvastatin
Ezetimibe

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Not provided

First Submitted Date

May 19, 2008

First Submission Date that Met QC Criteria

May 20, 2008

First Posted Date

May 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2010

Last Update Posted Date

Oct 19, 2010Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	ABT-335 135 mg	Drug: ABT-335
B	Experimental	Atorvastatin 80 mg and Ezetimibe 10 mg	Drug: Atorvastatin Drug: Ezetimibe
C	Experimental	ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg	Drug: ABT-335 Drug: Atorvastatin Drug: Ezetimibe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABT-335	Drug	One ABT-335 135 mg capsule QD for 10 days	A C

Measure	Description	Time Frame
PK interaction		Study duration approximately 62 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 8087		Gainesville	Florida	32608	United States

Intervention Browse Module

MeSH Terms

ID	Term
C533234	2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
C006012	fenofibric acid
D000069059	Atorvastatin
D000069438	Ezetimibe

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided