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A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01363999
First received: May 31, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
 Drug: dalcetrapib
Drug: atorvastatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Plasma concentration of dalcetrapib [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Plasma concentration of atorvastatin [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of atorvastatin metabolites [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dalcetrapib
single dose of dalcetrapib on day 1
Drug: atorvastatin
single dose of atorvastatin on day 1
Experimental: 2 Drug: dalcetrapib
single dose of dalcetrapib on day 1
Drug: atorvastatin
single dose of atorvastatin on day 1
Experimental: 3 Drug: dalcetrapib
single dose of dalcetrapib on day 1
Drug: atorvastatin
single dose of atorvastatin on day 1
Experimental: 4 Drug: dalcetrapib
single dose of dalcetrapib on day 1
Drug: atorvastatin
single dose of atorvastatin on day 1

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363999

Locations
New Zealand
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01363999     History of Changes
Other Study ID Numbers: WP25642
Study First Received: May 31, 2011
Last Updated: June 3, 2013
Health Authority: New Zealand: Health and Disability Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013