Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers
Condition: Healthy
Intervention: MSC2499550A; Cysticide; MSC2499550A; MSC2499550A; MSC2499550A; MSC2499550A
Intervention description: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each intervention period.; Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.; Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Intervention MeSH terms: Praziquantel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Praziquantel; L-PZQ; PZQ; MSC2499550A; Bioavailability; Pharmacokinetics

Summary:

      This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The
      purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ
      [MSC2499550A]) oral dispersible tablet (ODT) formulation (150 milligram [mg]) versus the
      current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male
      volunteers under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males aged 18-55 years of age (inclusive at screening)

          -  Male subjects with partners of childbearing potential must have had a vasectomy or use
             acceptable methods of birth control (that is, condoms) and not donate sperm during,
             and until 90 days after the last dose of the trial medication

          -  Written informed consent prior to any trial related procedure

          -  Have a body weight of greater than or equal to (>=) 55.0 kilogram (kg) to less than
             (<) 95.0 kg and a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter
             (kg/m^2) (inclusive)

          -  Able to communicate well with the Investigator, understanding the protocol
             requirements and restrictions, and willing to comply with the requirements of the
             entire trial

          -  Non-smoker (= 0 cigarettes, pipes, cigars or others) since at least 3 months

          -  Electrocardiogram (ECG) recording (12-lead) without signs of clinically relevant
             pathology in particular corrected QT Interval (QTc) (Bazett) < 450 milliseconds (ms)

          -  Vital signs (systolic and diastolic blood pressure, pulse) in supine position and body
             temperature within the normal range or showing no clinically relevant deviation as
             judged by the medical Investigator

        Exclusion Criteria:

          -  Any surgical or medical condition, including findings in the medical history or in the
             prestudy assessments, or any other significant disease, that in the opinion of the
             Investigator, constitutes a risk or a contraindication for the participation of the
             subject in the study or that could interfere with the study objectives, conduct or
             evaluation

          -  History of surgery of the gastrointestinal tract (GI), history of other GI tract
             diseases, or acute GI tract infections in the last 2 weeks, which could influence the
             GI absorption and/or motility according to the Investigator's opinion

          -  Any clinically relevant abnormality in the safety laboratory parameters as judged by
             the Investigator

          -  Have positive results from serology examination for Hepatitis B surface antigen
             (HBsAg), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)

          -  Allergy: ascertained or presumptive hypersensitivity to the active drug substance
             and/or formulations ingredients; history of anaphylaxis to drugs or allergic reactions
             in general, which the Investigator considers may affect the outcome of the trial

          -  History or presence of drug abuse (amphetamines, barbiturates, benzodiazepines,
             cocaine, opiates, phencyclidine (phenylcyclohexalpiperidine), tetrahydrocannabinol,
             tricyclic antidepressants, methadone, methamphetamine, oxycodone and propoxyphene) or
             alcohol abuse at screening and on each admission as defined by the Investigator

          -  Loss or donation of more than 400 milliliter (mL) of blood within 90 days prior to
             first praziquantel (PZQ) administration

          -  Administration of any investigational product or use of any investigational device
             within 60 days prior to first PZQ administration

          -  Subjects who have used drugs that may affect the pharmacokinetics (PK) of PZQ from 14
             days before dosing until the last PK sample, for example, phenytoin, barbiturates,
             primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin,
             nelfinavir, ritonavir, griseofulvin, oral ketoconazole, on discretion of the
             Investigator

          -  Consumption of substances known to be potent inhibitors or inducers of cytochrome
             -P450 enzymes (CYP P450s) such as grapefruit juice, grapefruit juice containing
             products, and herbal remedies or dietary supplements containing St. John's Wort, in
             the 2 weeks before dosing

          -  Unlikely to comply with the protocol requirements, instructions and trial-related
             restrictions, for example, uncooperative attitude, inability to return for follow-up
             visits, and improbability of completing the trial

          -  Non-acceptance of study breakfast (for example, vegetarians, vegans and subjects who
             follow special diets)

          -  Excessive consumption of beverages -containing xanthine (> 5 cups ) of coffee a day,
             or equivalent or inability to stop consuming caffeine from 48 hours prior to drug
             administration until discharge from the clinic

          -  Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist,
             trial coordinator, other staff or relative thereof directly involved in the conduct of
             the trial

          -  Vulnerable subjects (for example, persons kept in detention)

          -  Legal incapacity or limited legal capacity