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Trial registered on ANZCTR


Registration number
ACTRN12611000315910
Ethics application status
Approved
Date submitted
23/03/2011
Date registered
24/03/2011
Date last updated
24/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
To determine whether a pharmacokinetic drug-drug interaction occurs between atorvastatin and elinogrel.
Scientific title
An open-label, single sequence study to assess the potential pharmacokinetic drug-drug interaction of elinogrel and atorvastatin at steady-state in healthy adult subjects
Secondary ID [1] 259845 0
Nil
Universal Trial Number (UTN)
U1111-1119-9093
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic coronary heart disease (CHD) 265418 0
Condition category
Condition code
Cardiovascular 265578 265578 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo a single sequence 3 treatment period as outlined below. Treatment periods are without overlap and with at least 5 days seperating each treatment period.

There will be three treatment phases.
Treatment 1 (Period 1 – 5 days)
Elingrel at a dose of 150 mg twice a day for 5 days.

Treatment 2 (Period 2 – 10 days)
atorvastatin at a dose of 40 mg once a day for the first 5 days followed by
Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 40 mg once a day for the last 5 days. There will be no evening dose on the last day.

Treatment 3 (Period 3 – 10 days)
atorvastatin at a dose of 80 mg once a day for the first 5 days followed by
Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 80 mg once a day for the last 5 days. There will be no evening dose on the last day.
Intervention code [1] 264264 0
Treatment: Drugs
Comparator / control treatment
There is no control/comparator for the study. This is a single group trial. The same intervention is applied to all subjects in the study.

All subjects undergo all 3 treatment periods, one after another (consecetivley) with at least 5 days seperating treatment periods.
All subjects are adminstered atorvastatin and elinogrel at the same dose in the same sequence during the same treatment periods
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262375 0
To characterize the pharmacokinetics of atorvastatin following once a day dosing alone and in combination with elinogrel in healthy volunteers.
Timepoint [1] 262375 0
PK blood samples will be drawn using a needle and a cannula from just prior to the morning dose given on day 10 of treatment period 2 to 24 hrs after the morning dose
Primary outcome [2] 262376 0
To characterize the pharmacokinetics of elinogrel following twice a day dosing alone and in combination with atorvastatin in healthy volunteers.
Timepoint [2] 262376 0
PK blood samples will be drawn using a needle and a cannula from just prior to the morning dose given on day 10 of treatment period 3 to 24 hrs after the morning dose
Secondary outcome [1] 273653 0
To assess the safety and tolerability of elinogrel and atorvastatin co-administration in healthy volunteers
Timepoint [1] 273653 0
PK blood samples will be drawn using a needle and a cannula from just prior to the morning dose given on day 10 of treatment period 2 and 3 to 24 hrs after the morning dose

Eligibility
Key inclusion criteria
Healthy male and female subjects aged 18 to 45 (inclusive), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline. All evaluations must be within normal range for age and gender, or considered ‘not clinically meaningful’ if outside the normal range.

Body mass index (BMI) must be 18 – 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg.
Vital signs (after 3 minutes in seated position) must be within stated ranges.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
PT (INR), aPTT, platelet count, bleeding time (in excess of 10 min), stool occult blood and microscopic hemoglobinuria, at screening or baseline are outside the normal range of the laboratory. INR below the lower limit of the local laboratory normal range isacceptable (but no lower than 0.9) at the investigators discretion.

Facial or head trauma, intraocular hemorrhage, fractures within 30 days of Screening.

History of any prior ischemic stroke or TIA within the last 5 years or intracranial hemorrhage, neoplasm, arteriovenous malformation, bleeding disorder or coagulation disorders which is considered clinically significant by the investigator.

Known contraindication to the investigational compound, compound class (e.g. atorvastatin, clopidogrel glycoprotein IIb/IIIa inhibitors etc.).

Smokers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2011
Actual
7/04/2011
Date of last participant enrolment
Anticipated
Actual
6/05/2011
Date of last data collection
Anticipated
Actual
15/11/2011
Sample size
Target
28
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 264718 0
Commercial sector/Industry
Name [1] 264718 0
Novartis Pharmaceutical Pty Limited
Country [1] 264718 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceutical Pty Limited
Address
54 waterloo rd
North Ryde NSW 2113
Australia
Country
Australia
Secondary sponsor category [1] 263843 0
None
Name [1] 263843 0
Address [1] 263843 0
Country [1] 263843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266707 0
Alfred Health Ethics committee
Ethics committee address [1] 266707 0
Ethics committee country [1] 266707 0
Australia
Date submitted for ethics approval [1] 266707 0
05/04/2011
Approval date [1] 266707 0
04/04/2011
Ethics approval number [1] 266707 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32375 0
A/Prof Peter Hodsman
Address 32375 0
Austin Center for clinical trials
Level 9, Harold Stokes building Austin Hospital
Burgundy St, Heidelberg VIC 3084,
Australia
Country 32375 0
Australia
Phone 32375 0
+ 613 8593 9800
Fax 32375 0
Email 32375 0
Peter.Hodsman@nucleusnetwork.com
Contact person for public queries
Name 15622 0
Lisa Nelson
Address 15622 0
Austin Hospital
145 Studley Rd,
Heidelberg VIC 3084,
Australia
Country 15622 0
Australia
Phone 15622 0
+ 613 8593 9800
Fax 15622 0
+ 613 9076 8911
Email 15622 0
karissa.fitzgerald@novartis.com
Contact person for scientific queries
Name 6550 0
Dr Shibadas Biswal
Address 6550 0
6W 007
Novartis Healthcare Pvt.Ltd.,
Building no. 6, Mind Space, Raheja IT Park,
Hitec City, Madhapur,Hyderabad, 500 081, India
Country 6550 0
India
Phone 6550 0
+91 40 6767 4607
Fax 6550 0
+91 40 6767 1600
Email 6550 0
shibadas.biswal@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.