Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000640000
Ethics application status
Approved
Date submitted
5/08/2010
Date registered
6/08/2010
Date last updated
24/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of potential effects of elinogrel on steady-state pharmacokinetics of atorvastatin in healthy adult subjects
Scientific title
An open-label, randomized, 2-way, cross-over study, to assess the potential effect of elinogrel on the steady-state pharmacokinetics of atorvastatin in healthy adult subjects
Secondary ID [1] 252383 0
No secondary ID
Universal Trial Number (UTN)
U1111-1116-3890
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute coronary syndromes 257894 0
Condition category
Condition code
Cardiovascular 258055 258055 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atorvastatin 40 mg (oral tablet) once daily (QD) plus Elinogrel 150mg (oral capsule) twice daily (BD) for 5 days (treatment 2)

Each participant will take both treatments 1 and 2. One at a time, seperated by a 5 day washout period. The treatment taken first will depend on randomistion (similar to the flip of a coin)
Intervention code [1] 256955 0
Treatment: Drugs
Comparator / control treatment
Atorvastatin 40 mg (oral tablet) once daily (QD) alone for 5 days (treatment 1). Patients in this arm will not take Elinogrel.
Control group
Active

Outcomes
Primary outcome [1] 258915 0
Pharmacokinetic samples.
Steady state pharmacokinetics of multiple doses of atorvastatin when adminstered with and without elinogrel in healthy adults
Timepoint [1] 258915 0
24 hours after the morning dose given on day 5 of each treatment period
Secondary outcome [1] 265080 0
Safety assessments (electrocardiogram (ECG), vitals signs including pulse rate, blood pressure, body temperature, safety bloods, hematology, biochemistry and urinalysis, bleeding time tests, fecal occult blood, adverse events and serious adverse events)
Timepoint [1] 265080 0
From the time of first dose until the end of study visit.

Eligibility
Key inclusion criteria
- adult subjects aged 18 to 45
- Body Mass Index (BMI) between 18 and 32 Kg/m2
- Change between seated and standing blood pressure less than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Women of childbearing potential unless using suitable contraception methods
- Bleeding time tests out of normal laboratory range
- Abnormal liver function test results
- Other protocol-defined inclusion/exclusion criteria may apply

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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2010
Actual
11/08/2010
Date of last participant enrolment
Anticipated
Actual
11/10/2010
Date of last data collection
Anticipated
Actual
9/11/2010
Sample size
Target
24
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257398 0
Commercial sector/Industry
Name [1] 257398 0
Novartis Pharmaceutical Pty Ltd
Country [1] 257398 0
Australia
Primary sponsor type
Other
Name
Nucleus Network
Address
Level 5 Burnet Institute
Alfred Medical Research Education Precinct (AMREP)
89 Commercial Road, Melbourne
Victoria 3004
Country
Australia
Secondary sponsor category [1] 256632 0
Hospital
Name [1] 256632 0
Alfred Health
Address [1] 256632 0
89 Commercial Road, Melbourne
Victoria 3004
Country [1] 256632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259419 0
Alfred Health
Ethics committee address [1] 259419 0
89 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 259419 0
Australia
Date submitted for ethics approval [1] 259419 0
30/06/2010
Approval date [1] 259419 0
02/08/2010
Ethics approval number [1] 259419 0

Summary
Brief summary
Elinogrel is under development for the treatment of patients with chronic coronary heart disease and acute coronary syndromes.
Patients treated for these conditions are likley to be on a statin therapy such as atorvastatin in addition to other anticoagulants such as elinogrel.
Hence the need to investigate the potential drug-drug interaction between elinogrel and atorvastatin.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31478 0
Address 31478 0
Country 31478 0
Phone 31478 0
Fax 31478 0
Email 31478 0
Contact person for public queries
Name 14725 0
Karissa Fitzgerald
Address 14725 0
54 Waterloo Rd
North Ryde NSW 2113
Country 14725 0
Australia
Phone 14725 0
+61 2 9805 3447
Fax 14725 0
Email 14725 0
karissa.fitzgerald@novartis.com
Contact person for scientific queries
Name 5653 0
Christian Skulina
Address 5653 0
54 Waterloo Rd
North Ryde NSW 2113
Country 5653 0
Australia
Phone 5653 0
+61 2 9805 3518
Fax 5653 0
Email 5653 0
christian.skulina@novartis.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.