A clinical trial to check activity of certain enzymes in the body after taking a drug called AEB071

An open-label, single-sequence pharmacokinetic study in healthy subjects to assess the potential of AEB071 to inhibit and induce CYP1A2 using caffeine as a probe substrate

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000582

Enrollment

Registered

2009-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: AEB071: 300mg orally twice-daily for 10 days Intervention2: Caffiene: 100mg Orally Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Non-smokers Age: 18 to 45 years Good health conditions Post-menopausal or surgically sterilised females

Exclusion criteria

Exclusion criteria: Use of any prescription drugs within 4weeks prior to dosing. Donation or loss of 400ml or more blood. Significant illness subjects. No significant ECG abnormalities. History of immunodefficiency disease.

Design outcomes

Primary

Measure	Time frame
to quantify the change from baseline in caffeine pharmacokinetics when co-administered with single dose of AEB071Timepoint: NIL	—

Secondary

Measure	Time frame
to assess safety and tolerability of AEB071 during multiple dose administration in healthy subjects alone and when combined with caffeineTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr. Vinu Jose

Novartis Healthcare Pvt. Ltd.

vinu.jose@novartis.com04067672946

Outcome results