SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, TWO-PARTS, TWO-WAY CROSSOVER STUDY TO INVESTIGATE THE EFFECTS ON HEART RATE, BLOOD PRESSURE, AND PHARMACOKINETIC INTERACTIONS OF ACT-128800 COMBINED WITH A CALCIUM-CHANNEL BLOCKER OR A BETA-BLOCKER IN HEALTHY SUBJECTS - ACT-128800 DDI study

Actelion Pharmaceuticals0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Age: 18-60 years, inclusive (at screening)
•BMI: 18.0-30.0 kg/m2, inclusive;Women of childbearing potential must:
•- have a negative serum pregnancy test at screening and prior to first drug intake;
•- agree to use two methods of contraception from the screening visit until 2 months after study drug discontinuation.;Systolic blood pressure 100*150 mmHg, diastolic blood pressure 50*90 mmHg measured on the right arm, and HR 55*95 bpm (inclusive)

•- Pregnant or lactating woman.
•- Known hypersensitivity to any excipients of the study drug formulation
•- Known hypersensitivity to atenolol or diltiazem or any of their excipients
•- Veins unsuitable for i.v. puncture on either arm
•- Treatment with another investigational drug within 3 months prior to screening.
•- Excessive caffeine consumption, defined as > 800 mg per day at screening.
•- Smoking or nicotine replacement therapy within the last month prior to screening.
•- Any immunosuppressive treatment within 6 weeks before study drug administration.
•- Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St John*s Wort) within 2 weeks prior to screening or 5 half-lives of the drug, whichever is longer (except for contraceptives).
•- Loss of 250 mL or more of blood within 3 months prior to screening.
•- Positive hepatitis B surface antigen or hepatitis C antibody tests or positive results for HIV serology, at screening
•- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject*s full participation in the study or compliance with the protocol.

发起方

Actelion Pharmaceuticals