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A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01363999
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: atorvastatin Drug: dalcetrapib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: atorvastatin
single dose of atorvastatin on day 1

Drug: dalcetrapib
single dose of dalcetrapib on day 1

Experimental: 2 Drug: atorvastatin
single dose of atorvastatin on day 1

Drug: dalcetrapib
single dose of dalcetrapib on day 1

Experimental: 3 Drug: atorvastatin
single dose of atorvastatin on day 1

Drug: dalcetrapib
single dose of dalcetrapib on day 1

Experimental: 4 Drug: atorvastatin
single dose of atorvastatin on day 1

Drug: dalcetrapib
single dose of dalcetrapib on day 1




Primary Outcome Measures :
  1. Plasma concentration of dalcetrapib [ Time Frame: 3 days ]
  2. Plasma concentration of atorvastatin [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Plasma concentration of atorvastatin metabolites [ Time Frame: 3 days ]
  2. Safety: Incidence of adverse events [ Time Frame: 9 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363999


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01363999     History of Changes
Other Study ID Numbers: WP25642
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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