NL-OMON42430
Completed
Not Applicable
Double-blind, placebo-controlled, randomized study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-541468: Part A: Multiple-ascending doses in healthy young adults after morning administration. Part B: Single-ascending doses in healthy elderly subjects after morning administration. Part C: Repeated doses in both healthy young adults and elderly subjects after evening administration. - Tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-541468
Actelion Pharmaceuticals0 sites84 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleeping disorders
- Sponsor
- Actelion Pharmaceuticals
- Enrollment
- 84
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Signed informed consent in the local language prior to any study\-mandated procedure.
- •\- Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
- •\- Elderly (part B and C only): Healthy male and female subjects aged between 65 and 80 years (inclusive) at screening.
- •\- Subjects must have a regular sleep pattern of at least 6 hours nocturnal sleep.
- •\- Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test predose on Day 1\. Women of childbearing potential must consistently and correctly use (from screening, during the entire study, and for at least 90 days after last study drug intake) a reliable method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner. (Details about reliable contraceptive measures only to be given in the core protocol (not in the protocol outline)).
- •\- No clinically significant findings on the physical examination at screening.
- •\- Body mass index (BMI) of 18\.0 to 30\.0 kg/m2 (inclusive) at screening.
- •\- Systolic blood pressure (SBP) 100\-145 mmHg, diastolic blood pressure (DBP) 50\-90 mmHg, and pulse rate 45\-90 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at screening.
- •\- Elderly: SBP 100\-160 mmHg, diastolic blood pressure (DBP) 50\-95 mmHg, and pulse rate 45\-100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at screening.
- •\- 12\-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening.
Exclusion Criteria
- •\- Pregnant or lactating women.
- •\- Known hypersensitivity to the drug or drugs of the same class, or any of their excipients of the drug formulation.
- •\- Previous exposure to the study medication.
- •\- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •\- Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
- •\- Treatment with any prescribed medications (including vaccines) or over\-the\-counter (OTC) medications (including herbal medicines such as St. John\*s Wort) within 2 weeks prior to study drug administration.
- •\- Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
- •\- History or clinical evidence of alcoholism or drug abuse within the 3\-year period prior to screening.
- •\- History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study drugs (appendectomy and herniotomy allowed; cholecystectomy not allowed).
- •\- Excessive caffeine consumption, defined as \>\= 800 mg per day at screening.
Outcomes
Primary Outcomes
Not specified
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