Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 5 of 14 for:    jtt-705

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: November 3, 2014
Last verified: November 2014
  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 atorvastat in in each of four treatment periods.


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


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: 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

  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
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: 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: November 3, 2014
Health Authority: New Zealand: Health and Disability Ethics Committee

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

ClinicalTrials.gov processed this record on November 23, 2014