Trial · NCT02271984
Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers
NCT02271984, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-01-03
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ConductScience Library. Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers. Trials, record NCT02271984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02271984
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers
- NCT number
- NCT02271984
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Healthy
- Interventions
- MSC2499550A, Cysticide, MSC2499550A, MSC2499550A, MSC2499550A, MSC2499550A
- First posted
- 2014-10-22
- Last updated
- 2018-01-03
- Results first posted
- 2018-01-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. |
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | |
| Secondary | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | Time prior to the first measurable (non-zero) concentration (tlag) of drug L-PZQ |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of L-Praziquantel (L-PZQ) After Dose Adjustment | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration at or above the lower limit of quantification (AUC0-t) of L-PZQ. |
| Secondary | Extrapolated Area Under the Concentration Time Curve (AUC) From Time Tlast to Infinity Given as Percentage From AUC0-inf (AUCextra) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | Extrapolated AUC from time tlast to infinity given as percentage from AUC0-inf. AUCextra =(last predicted concentration \[Clast pred\] divided by terminal elimination rate constant \[lambda z\]) divided by AUC0-inf., where Clast pred is the last predicted concentration. |
| Secondary | Maximum Observed Concentration in Plasma (Cmax) of L-Praziquantel (L-PZQ) After Dose Adjustment | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | |
| Secondary | Apparent Terminal Half-life (T1/2) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The apparent terminal half-life was calculated by dividing natural log 2 with lambda z (ln2/lambda Z); where lambda Z is the terminal rate constant. |
| Secondary | Relative Bioavailability (Frel) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | Relative bioavailability (Frel) was calculated for L-PZQ only (treatment A versus treatment B) using the formula: Frel = (AUC0-inf (test or Treatment A)/AUC0-inf (reference or treatment B)) multiplied by 100. |
| Secondary | Apparent Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The lambda z was calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. |
| Secondary | Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The CL/f of L-PZQ was a measure of the rate at which it was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. The CL/F of L-PZQ from plasma was calculated using the formula: Dose divided by area under the concentration time curve from time zero to infinity (AUC0-inf). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results \& availability of AUC0-inf for MSC2499550A in periods 1 \& 2. Number of participants analyzed below (Measured Values) reflects number of participants with non-missing values. | hour*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2. | hour | MEDIAN |
| SECONDARY | Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2. | hour | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of L-Praziquantel (L-PZQ) After Dose Adjustment | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2. | hour*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Extrapolated Area Under the Concentration Time Curve (AUC) From Time Tlast to Infinity Given as Percentage From AUC0-inf (AUCextra) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results \& availability of AUC0-inf for MSC2499550A in periods 1 \& 2. Number of participants analyzed below (Measured Values) reflects number of participants with non-missing values. | Percent extrapolated | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Concentration in Plasma (Cmax) of L-Praziquantel (L-PZQ) After Dose Adjustment | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The PK population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Terminal Half-life (T1/2) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results \& availability of AUC0-inf for MSC2499550A in periods 1 \& 2. Number of participants analyzed below (Measured Values) reflects number of participants with non-missing values. | hour | MEDIAN |
| SECONDARY | Relative Bioavailability (Frel) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | The PK population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2. | Percentage bioavailability | GEOMETRIC_MEAN |
| SECONDARY | Apparent Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results \& availability of AUC0-inf for MSC2499550A in periods 1 \& 2. Number of participants analyzed below (Measured Values) reflects number of participants with non-missing values. | per hour (1/hour) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-Praziquantel (L-PZQ) | Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose | PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results \& availability of AUC0-inf for MSC2499550A in periods 1 \& 2. Number of participants analyzed below (Measured Values) reflects number of participants with non-missing values. | Liter per hour | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group145
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Treatment A | 825.2 | Geometric Coefficient of Variation 101.0 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Treatment B | 2066.0 | Geometric Coefficient of Variation 64.7 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Treatment C1 | 216.7 | Geometric Coefficient of Variation 102.8 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Treatment C2 | 2324.9 | Geometric Coefficient of Variation 76.4 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Treatment D | 506.2 | Geometric Coefficient of Variation 100.0 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment | Treatment E | 954.5 | Geometric Coefficient of Variation 96.4 | hour*nanogram per milliliter (h*ng/mL) | |
| Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) | Treatment A | 2.500 | Full Range 0.50 to 4.50 | hour | |
| Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) | Treatment B | 2.500 | Full Range 1.00 to 4.50 | hour | |
| Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) | Treatment C1 | 2.250 | Full Range 1.00 to 4.50 | hour | |
| Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) | Treatment C2 | 3.000 | Full Range 1.00 to 4.50 | hour |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 results by groupParticipant flow324
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period (1 Day) | STARTED | ABC1DE | 3 | |
| First Intervention Period (1 Day) | STARTED | ABDEC1 | 3 | |
| First Intervention Period (1 Day) | STARTED | ABEC1D | 3 | |
| First Intervention Period (1 Day) | STARTED | BAC1DE | 3 | |
| First Intervention Period (1 Day) | STARTED | BADEC1 | 3 | |
| First Intervention Period (1 Day) | STARTED | BAEC1D | 3 | |
| First Intervention Period (1 Day) | STARTED | ABC2DE | 3 | |
| First Intervention Period (1 Day) | STARTED | ABDEC2 | 3 | |
| First Intervention Period (1 Day) | STARTED | ABEC2D | 3 | |
| First Intervention Period (1 Day) | STARTED | BAC2DE | 3 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 participant flowAdverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Discomfort | Gastrointestinal disorders | Treatment A | 0 | 36 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Treatment B | 1 | 36 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Treatment C1 | 1 | 18 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Treatment C2 | 0 | 17 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Treatment D | 0 | 35 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Treatment E | 0 | 36 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment A | 0 | 36 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment B | 0 | 36 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment C1 | 0 | 18 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment C2 | 0 | 17 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A | ||
| Total, all-cause mortality | Treatment B | ||
| Total, all-cause mortality | Treatment C1 | ||
| Total, all-cause mortality | Treatment C2 | ||
| Total, all-cause mortality | Treatment D | ||
| Total, all-cause mortality | Treatment E | ||
| Total, other adverse events | Treatment A | 8 | 36 |
| Total, other adverse events | Treatment B | 17 | 36 |
| Total, other adverse events | Treatment C1 | 4 | 18 |
| Total, other adverse events | Treatment C2 | 4 | 17 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30536632 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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