A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

December 13, 2019 updated by: Hoffmann-La Roche

A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers

A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers, 18 to 55 years of age, inclusive

Exclusion Criteria:

  • Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
  • Clinically significant abnormal laboratory values

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
RO5317116/F01 bilayer tablet
Drug: atorvastatin
single dose of atorvastatin on day 1
Drug: dalcetrapib
single dose of dalcetrapib on day 1
Experimental: B
RO5317116/F03 bilayer tablet
Drug: atorvastatin
single dose of atorvastatin on day 1
Drug: dalcetrapib
single dose of dalcetrapib on day 1
Experimental: C
RO5317116/F04 active-coated tablet
Drug: atorvastatin
single dose of atorvastatin on day 1
Drug: dalcetrapib
single dose of dalcetrapib on day 1
Experimental: D
RO4607381/F49 tablet
Drug: atorvastatin
single dose of atorvastatin on day 1
Drug: dalcetrapib
single dose of dalcetrapib on day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma Concentration of Dalcetrapib Active Form
Time Frame: 3 days
3 days
Plasma Concentration of Atorvastatin
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration of Atorvastatin Metabolites
Time Frame: 3 days
Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.
3 days
Safety: Incidence of Serious Adverse Events
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP25642

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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