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: August 4, 2014
Last verified: August 2014

May 31, 2011
August 4, 2014
June 2011
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01363999 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
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 atorvastat in in each of four treatment periods.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: dalcetrapib
    single dose of dalcetrapib on day 1
  • Drug: atorvastatin
    single dose of atorvastatin on day 1
  • Experimental: 1
    Interventions:
    • Drug: dalcetrapib
    • Drug: atorvastatin
  • Experimental: 2
    Interventions:
    • Drug: dalcetrapib
    • Drug: atorvastatin
  • Experimental: 3
    Interventions:
    • Drug: dalcetrapib
    • Drug: atorvastatin
  • Experimental: 4
    Interventions:
    • Drug: dalcetrapib
    • Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01363999
WP25642
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP