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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01363999




Registration number
NCT01363999
Ethics application status
Date submitted
31/05/2011
Date registered
2/06/2011
Date last updated
17/12/2019

Titles & IDs
Public title
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
WP25642
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - atorvastatin
Treatment: Drugs - dalcetrapib

Experimental: A - RO5317116/F01 bilayer tablet

Experimental: B - RO5317116/F03 bilayer tablet

Experimental: C - RO5317116/F04 active-coated tablet

Experimental: D - RO4607381/F49 tablet


Treatment: Drugs: atorvastatin
single dose of atorvastatin on day 1

Treatment: Drugs: dalcetrapib
single dose of dalcetrapib on day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma Concentration of Dalcetrapib Active Form
Timepoint [1] 0 0
3 days
Primary outcome [2] 0 0
Plasma Concentration of Atorvastatin
Timepoint [2] 0 0
3 days
Secondary outcome [1] 0 0
Plasma Concentration of Atorvastatin Metabolites
Timepoint [1] 0 0
3 days
Secondary outcome [2] 0 0
Safety: Incidence of Serious Adverse Events
Timepoint [2] 0 0
9 weeks

Eligibility
Key inclusion criteria
- Healthy volunteers, 18 to 55 years of age, inclusive
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01363999
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01363999