An open-label, single-sequence pharmacokinetic study inhealthy subjects to assess the potential of AEB071 toinhibit and induce CYP1A2 using caffeine as a probesubstrate

Novartis Healthcare Pvt. Ltd.1 个研究点分布在 1 个国家目标入组 18 人开始时间: 待定

试验速览

阶段: 1 期
发起方
入组人数: 18
试验地点: 1
主要终点: to quantify the change from baseline in caffeine pharmacokinetics when co-administered with single dose of AEB071

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盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

•Non-smokersAge: 18 to 45 yearsGood health conditionsPost-menopausal or surgically sterilised females.

•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.

to quantify the change from baseline in caffeine pharmacokinetics when co-administered with single dose of AEB071

时间窗: NIL

to assess safety and tolerability of AEB071 during multiple dose administration in healthy subjects alone and when combined with caffeine(NIL)

发起方

Novartis Healthcare Pvt. Ltd.

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