Assessment of potential effects of elinogrel on steady-state pharmacokinetics of atorvastatin in healthy adult subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000640000

Enrollment

Registered

2010-08-06

Start date

2010-08-11

Completion date

2010-10-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

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

Outcome results