HealthyPhase 1NCT02325713
Relative Bioavailability Trial of Oral Dispersible Praziquantel Tablets in Healthy Volunteers
A Phase 1 study testing Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide and ODT-PZQ in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide and ODT-PZQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Mar 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide, ODT-PZQ
- Keywords
- ODT-PZQ, Bio-availability, Praziquantel, Cysticide, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral dispersible tablet of praziquantel (ODT-PZQ)Drug
Also called MSC1028703A
Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
CysticideDrug
Also called PZQ
Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
ODT-PZQDrug
Also called MSC1028703A
Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
ODT-PZQDrug
Also called MSC1028703A
Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
ODT-PZQDrug
Also called MSC1028703A
Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
CysticideDrug
Also called PZQ
Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A-B-C1-D1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-C1-D2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-C2-D1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-C2-D2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-D1-C1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-D2-C1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-D1-C2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence A-B-D2-C2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-C1-D1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-C1-D2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-C2-D1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-C2-D2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-D1-C1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-D2-C1 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-D1-C2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
| Sequence B-A-D2-C2 | Experimental | Not described Receives: Drug: Oral dispersible tablet of praziquantel (ODT-PZQ); Drug: Cysticide; Drug: ODT-PZQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ)
AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ.
Measured: Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Secondary outcomes (14)
Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ
Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ
AUCextra was reported in terms of percentage of AUC0-inf.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ
λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ
Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ
AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of D-PZQ and Racemate PZQ.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug.
Measured: Baseline up to end of treatment (up to Day 32)
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Palatability was assessed in terms of Flavor, Smell, Sweetness, Overall liking of the medicine, Taste and Acceptability to swallow, each parameter assessed on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 indicates "Did not like" and 100 indicates "very much liked". Flavor, Smell, Sweetness and Overall liking of the medicine were evaluated immediately after taking the medication (Day 1, 0 Hour) and Taste and Acceptability to swallow were assessed 2-5 minutes post administration of medication.
Measured: Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment
Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters
Vital signs included oral body temperature, blood pressure and pulse rate. Body weight was recorded for physical examinations. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation including chemistry, hematology and urinalysis.
Measured: Baseline up to end of treatment (up to Day 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325713
- Sponsor's protocol ID
- 200585-001
- Status last verified
- Jan 2017
- First submitted
- 11 Dec 2014
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02325713
- Acronym / sponsor ID
- 200585-001
- Conditions
- Healthy
- Keywords
- ODT-PZQ, Bio-availability, Praziquantel, Cysticide, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Sequence A-B-C1-D1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-C1-D2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-C2-D1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-C2-D2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-D1-C1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-D2-C1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-D1-C2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence A-B-D2-C2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-C1-D1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-C1-D2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-C2-D1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-C2-D2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-D1-C1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-D2-C1 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-D1-C2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
| Sequence B-A-D2-C2 | Experimental | Drug: Oral dispersible tablet of praziquantel (ODT-PZQ), Drug: Cysticide, Drug: ODT-PZQ |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral dispersible tablet of praziquantel (ODT-PZQ)Also: MSC1028703ATreatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal. | Drug | Sequence A-B-C1-D1, Sequence A-B-C1-D2, Sequence A-B-C2-D1, Sequence A-B-C2-D2, Sequence A-B-D1-C1, Sequence A-B-D1-C2, Sequence A-B-D2-C1, Sequence A-B-D2-C2, Sequence B-A-C1-D1, Sequence B-A-C1-D2, Sequence B-A-C2-D1, Sequence B-A-C2-D2, Sequence B-A-D1-C1, Sequence B-A-D1-C2, Sequence B-A-D2-C1, Sequence B-A-D2-C2 |
| CysticideAlso: PZQTreatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal. | Drug | Sequence A-B-C1-D1, Sequence A-B-C1-D2, Sequence A-B-C2-D1, Sequence A-B-C2-D2, Sequence A-B-D1-C1, Sequence A-B-D1-C2, Sequence A-B-D2-C1, Sequence A-B-D2-C2, Sequence B-A-C1-D1, Sequence B-A-C1-D2, Sequence B-A-C2-D1, Sequence B-A-C2-D2, Sequence B-A-D1-C1, Sequence B-A-D1-C2, Sequence B-A-D2-C1, Sequence B-A-D2-C2 |
| ODT-PZQAlso: MSC1028703ATreatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal. | Drug | Sequence A-B-C1-D1, Sequence A-B-C1-D2, Sequence A-B-D1-C1, Sequence A-B-D2-C1, Sequence B-A-C1-D1, Sequence B-A-C1-D2, Sequence B-A-D1-C1, Sequence B-A-D2-C1 |
| ODT-PZQAlso: MSC1028703ATreatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal. | Drug | Sequence A-B-C2-D1, Sequence A-B-C2-D2, Sequence A-B-D1-C2, Sequence A-B-D2-C2, Sequence B-A-C2-D1, Sequence B-A-C2-D2, Sequence B-A-D1-C2, Sequence B-A-D2-C2 |
| ODT-PZQAlso: MSC1028703ATreatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal. | Drug | Sequence A-B-C1-D1, Sequence A-B-C2-D1, Sequence A-B-D1-C1, Sequence A-B-D1-C2, Sequence B-A-C1-D1, Sequence B-A-C2-D1, Sequence B-A-D1-C1, Sequence B-A-D1-C2 |
| CysticideAlso: PZQTreatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal. | Drug | Sequence A-B-C1-D2, Sequence A-B-C2-D2, Sequence A-B-D2-C1, Sequence A-B-D2-C2, Sequence B-A-C1-D2, Sequence B-A-C2-D2, Sequence B-A-D2-C1, Sequence B-A-D2-C2 |
Primary outcome
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ.
14 secondary outcomes
Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment
Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation
Time frame: Baseline up to end of treatment (up to Day 32)
Palatability Assessment Based on Visual Analog Scale (VAS) Score
Time frame: Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment
Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters
Time frame: Baseline up to end of treatment (up to Day 32)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral dispersible tablet of praziquantel (ODT-PZQ), Cysticide and ODT-PZQ in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ) (time frame: Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.