Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Healthy |
| Intervention | Drug: ODT-PZQ Drug: Cysticide Drug: ODT-PZQ Drug: ODT-PZQ Drug: ODT-PZQ Drug: Cysticide |
| Phase | Phase 1 |
| Sponsor | Merck KGaA |
| Responsible Party | Merck KGaA |
| ClinicalTrials.gov Identifier | NCT02325713 |
| First Received | December 11, 2014 |
| Last Updated | December 21, 2014 |
| Last verified | December 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 11, 2014 |
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| Last Updated Date | December 21, 2014 |
| Start Date | January 2015 |
| Estimated Primary Completion Date | March 2015 |
| Current Primary Outcome Measures | Area under the plasma concentration-time curve (AUC) from time zero to Infinity (AUC0-inf) of L-PZQ [Time Frame: 0-24 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers |
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| Official Title | A Phase I, Open-label, Randomized, Four-period, Crossover, Single Center Trial to Assess the Relative Bioavailability of a Single Oral Dose of the New 150 mg Oral Dispersible Tablet (ODT) Formulation of Praziquantel (PZQ), MSC1028703A, at Different Dose Levels vs the Current Commercial 500 mg Tablet Formulation of PZQ in Healthy Male Volunteers |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Healthy |
| Intervention | Drug: ODT-PZQ ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal Other Names: MSC1028703ADrug: Cysticide Cysticide tablet at a single dose of 40 mg/kg given with water orally after a meal Other Names: PZQDrug: ODT-PZQ ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal Other Names: MSC1028703ADrug: ODT-PZQ ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal Other Names: MSC1028703ADrug: ODT-PZQ ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal Other Names: MSC1028703ADrug: Cysticide Cysticide crushed tablets at a single dose of 40 mg/kg given with water orally after a meal Other Names: PZQ |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 32 |
| Estimated Completion Date | March 2015 |
| Estimated Primary Completion Date | March 2015 |
| 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 |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02325713 |
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| Other Study ID Numbers | 200585-001 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Merck KGaA |
| Study Sponsor | Merck KGaA |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Responsible Merck KGaA |
| Verification Date | December 2014 |
Locations[ + expand ][ + ]
| Please contact the Merck KGaA Communication Center | Darmstadt, Germany Not yet recruiting |
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