Immune disease
Conditions
Interventions
Active substance: ACT-128800, atenolol, diltiazem extended release
Sponsors
Actelion Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiodynamics (telemetry) Pharmacokinetics Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
Netherlands
Outcome results
None listed