Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
Condition: Healthy
Intervention: Oral dispersible tablet of praziquantel (ODT-PZQ); Cysticide; ODT-PZQ; ODT-PZQ; ODT-PZQ; Cysticide
Intervention description: Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.; Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.; Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.; Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.; Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.; Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
Intervention MeSH terms: Praziquantel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ODT-PZQ; Bio-availability; Praziquantel; Cysticide; Pharmacokinetics

Summary:

      This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The
      purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible
      Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed
      praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males 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

          -  Provide written informed consent prior to any trial related procedure

          -  Body weight of greater than or equal to (>=)55.0 kg to less than (<) 95.0 kg and a
             body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)

          -  Able to communicate well with the Investigator, understand the protocol requirements
             and restrictions, and willing to comply with the requirements of the entire trial

          -  Non-smoker (= 0 cigarettes, pipes, cigars or other) from at least 3 months prior to
             start of trial

          -  Electrocardiogram (ECG) recording (12-lead) without signs of clinically relevant
             pathology, in particular QTcB < 450 milliseconds (ms)

          -  Vital signs (systolic blood pressure, diastolic blood pressure and pulse) in supine
             position are within the normal range or show no clinically relevant deviation as
             judged by the Investigator

        Exclusion Criteria:

          -  Any surgical or medical condition, including findings in the medical history or in the
             pre-study 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 trial or that could interfere with the trial objectives, conduct or
             evaluation

          -  History of gastrointestinal (GI) tract surgery, other GI tract diseases or acute GI
             tract infections within the last 2 weeks that 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

          -  Positive results from serology examination for Hepatitis B surface antigen (HBsAg),
             Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)

          -  Have an ascertained or presumptive contraindication or hypersensitivity to the active
             drug substance and/or formulations' ingredients

          -  Have any clinically significant history of allergic conditions which the Investigator
             considers may affect the outcome of the trial

          -  History or presence of drug abuse or alcohol abuse (as defined by the assessment of
             the investigator) at screening and on each admission

          -  Blood donation or loss of more than 400 mL of blood within 3 months before the first
             administration of the investigational product

          -  Administration of any investigational product or use of any investigational device
             within 60 days prior to first dosing that may affect the pharmacokinetics of the
             investigational product

          -  Subjects who have used drugs that may affect the pharmacokinetics (PK) of PZQ from 15
             days before the first administration of the investigational product until the last PK
             sample

          -  Consumption of substances known to be potent inhibitors or inducers of cytochrome
             P450s (CYPs) within 2 weeks before the first administration of the investigational
             product

          -  Unlikely to comply with the protocol requirements, instructions and trial-related
             restrictions

          -  Non-acceptance of the study breakfast

          -  Excessive consumption of beverages containing xanthine (greater than [>] 5 cups of
             coffee a day or equivalent) and the inability to refrain from the use of
             caffeine-containing beverages from 48 hours before the first administration of the
             investigational product 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

          -  Legal incapacity or limited legal capacity