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
- Conditions
- Immune disease10027665
- Registration Number
- NL-OMON36345
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cardiodynamics (telemetry)<br /><br>Pharmacokinetics<br /><br>Safety</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>