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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.
EU CTIS ID: 2023-505769-98-00
What this study is testing
To compare the pharmacokinetic (PK) parameters of pitolisant, its main identified metabolites (BP2.951, BP1.8054, BP1.9733, BP1.3484, BP1.3473, BP1.10556 and BP1.10749), after a single oral administration of 40 mg pitolisant hydrochloride of each of the new formulated tablets versus the reference formulation (Wakix®), in fasting conditions, in healthy male subjects.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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,
You likely can't join if
- Predictable poor compliance or inability to communicate well with the Investigator,
- 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,
- 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,
- 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,
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Predictable poor compliance or inability to communicate well with the Investigator,
- 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,
- 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,
- 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,
- Positive alcohol breath test at screening or at determination performed before the first dosing,
- Positive serology to HIV (HIV1 and HIV2) and/or HCV antibodies, and/or hepatitis B surface antigen (HBsAg),
- 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,
- Unsuitable veins for repeated venipuncture
- Having any vaccination during the 2 weeks preceding the study screening,
- 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,
- 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.
- 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,
- History of additional risk factors for “Torsades de Pointe” (e.g., heart failure, hypokalemia, family history of Long QT Syndrome,
- 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,
- 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,
- 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,
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.