Open label, single-center, cross-over randomized, relative bioavailability study comparing 4 new BF2.649 (pitolisant) tablet formulations versus the reference pitolisant (Wakix®) tablet formulation after single oral administrations in healthy male subjects.

Ki vehet részt

• Has given written informed consent
• Male subject ≥ 18 and ≤ 50 years old,
• Healthy subject ascertained by detailed medical history and physical examination, including subject presenting a history of seasonal and/or contact allergy
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
• Normal laboratory tests or if abnormal, judged as not clinically significant by the Investigator,
• Subject should agree to use an efficient contraceptive mean i.e., barrier method or abstinence during the whole study duration and up to 5 times the drug half-life,
• Normal arterial BP and pulse rate or, if abnormal, judged as not clinically significant by the Investigator. Normal BP values are defined by: (i) Systolic BP (SBP) > 90 millimeters of mercury (mmHg) and < 145 mmHg after 5 minutes (min) in supine position, (ii) Diastolic BP (DBP) > 45 mmHg and < 90 mmHg after 5 min in supine position, (iii) HR > 40 beats per minute (bpm) and =< 90 bpm after 5 min in supine position
• Normal 12-lead ECG recording or, if abnormal, judged as not clinically significant by the Investigator. Normal ECGs are defined by: (i) HR [40-90 bpm], (ii) PR [120 -200 milliseconds (ms)], (iii) QRS < 120 ms, (iiii) QTcF < 450 ms, (iiiii) No clinically significant conduction disorders or significant arrhythmia

Ki nem vehet részt

• Intake of any food or any beverage containing grapefruit or grapefruit juice within 48 h prior to the first dosing and the inability to stop such intake during the study,
• Blood donation or loss of significant amount of blood within 2 months prior to the first dosing,
• Positive drug screen (amphetamines, benzodiazepines, cocaine, opiate class, barbiturates, and cannabinoids) at screening or at the determination performed before the first dosing,
• Receiving any immune suppressive treatment within 6 weeks before the study,
• Viral, systemic, fungal, bacterial or protozoal infection (flu like symptoms (cough, fever)) within 4 weeks before the study,
• Subject in the 2-month period of a previous study or currently participating in, or plan to participate, in an investigational drug or medical device study during the 2 months following study completion
• Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study,
• Intake of any medication (except paracetamol), including OTC medications and herbal products that could affect the outcome of the study, within 2 weeks prior to the first drug administration or less than 5 times the t1/2 of that drug, whichever is longer,
• Current drug or alcohol abuse [including regular alcohol drinking of more than 21 units per week (1 unit = 4 cL spirits or equivalent)] or a history of drug or alcohol abuse within 1 year before screening,
• Positive serology to HIV (HIV1 and HIV2) and/or HCV antibodies, and/or hepatitis B surface antigen (HBsAg),
• Presenting any suggestive clinical evidence of active or latent tuberculosis,
• Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject,
• Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the Investigator,
• History of asthma of allergic origin, history of drug and/or food allergy,
• Evidence of any clinically significant acute or chronic disease on direct questioning and physical examination, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection,
• Known hypersensitivity to any of the test materials or related compounds,
• History of additional risk factors for “Torsades de Pointe” (e.g., heart failure, hypokalemia, family history of Long QT Syndrome,
• Predictable poor compliance or inability to communicate well with the Investigator,
• Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center,
• Use of caffeine containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical center,
• Positive alcohol breath test at screening or at determination performed before the first dosing,
• Unsuitable veins for repeated venipuncture
• Having any vaccination during the 2 weeks preceding the study screening,