NL-OMON32705CompletedNot Applicable
A double-blind, randomized, placebo-controlled, double-dummy, four-way crossover study to investigate the drug-drug interactions of almorexant and ethanol in healthy subjects. - A study to investigate the interaction between almorexant and alcohol.
Actelion Pharmaceuticals0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Signed informed consent prior to any study-mandated procedure.
- •- Male or female aged between 18 and 65 years (inclusive) at screening.
- •- Women of childbearing potential must consistently and correctly practice (from screening, during the entire study, and for at least 1 month after study drug intake) a reliable method of contraception with a failure rate of < 1% per year (such as implants, injectables, combined oral hormonal contraceptives, some intrauterine devices), sexual abstinence, or vasectomised partner. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea at least 1 year), or surgically or naturally sterile.
- •- No clinically significant findings on the physical examination at screening.
- •- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) at screening.
- •- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (all inclusive), measured on the leading arm, after 5 minutes in the supine position at screening.
- •- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
- •- Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.
- •- Negative results from urine drug screen at screening.
- •- Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Exclusion Criteria
- •- Known hypersensitivity to any excipients of the drug formulations.
- •- Previous treatment with any prescribed or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort) within 7 days prior to screening except for contraceptives for females.
- •- Treatment with another investigational drug within 3 months prior to screening or having participated in more than 4 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 of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- •- Excessive caffeine consumption, defined as >= 800 mg per day at 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.
- •- Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study.
- •- Loss of 250 mL or more of blood within 3 months prior to screening.
- •- Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- •- Positive results from the HIV serology at screening.
- •- Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
- •- Breast-feeding females.
- •- Individuals of Asian descent or other individuals reporting ethanol intolerance (Asian descent defined as: either the individual, or 1 or more parent or grandparent of Asian origin).
- •- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •- Legal incapacity or limited legal capacity at screening.
Investigators
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