Trial · NCT03480243
Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
NCT03480243, Phase 1, Completed, UCB Biopharma S.P.R.L.; results first posted 2021-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil. Trials, record NCT03480243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03480243
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil
- NCT number
- NCT03480243
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Pharmacokinetics
- Interventions
- Padsevonil (UCB0942), Erythromycin
- First posted
- 2018-03-29
- Last updated
- 2021-07-12
- Other registries' IDs
- eudract:2017-004694-13
- Results first posted
- 2021-07-12
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose | Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26 | Cmax: The maximum observed plasma concentration of padsevonil for single dose . Cmax was expressed in nanograms per milliliter (ng/mL). |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose | Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26 | AUC(0-12): The area under the plasma concentration-time curve from time zero to 12 hours of padsevonil for single dose . AUC(0-12) was expressed in hours times nanograms per milliliter (hours\*ng/mL). |
| Primary | Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL). |
| Primary | Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | AUCtau: The area under the plasma concentration-time curve over a dosing interval (12 hours) of padsevonil for multiple doses. AUC(tau) was expressed in hours times nanograms per millilitre (hours\*ng/mL). |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose | Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period | Tmax: The time of maximum plasma concentration of padsevonil for single dose. Tmax was expressed in hours (h). |
| Secondary | Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose | Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period | Cmin: The minimum observed plasma concentration of padsevonil for single dose. Cmin was expressed in nanograms per millilitre (ng/mL). |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | Tmax: The time of maximum plasma concentration of padsevonil for multiple doses. Tmax was expressed in hours (h). |
| Secondary | Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | t½,ss: The apparent terminal elimination half-life at steady-state of padsevonil for multiple doses in plasma. t1/2, ss was expressed in hours (h). |
| Secondary | Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | Ctrough: The predose observed plasma concentration of padsevonil for multiple doses. Ctrough was expressed in nanograms per millilitre (ng/mL). |
| Secondary | Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | CL/Fss: The apparent total clearance at steady-state of padsevonil for multiple doses in plasma. CL/Fss was expressed in milliliters per hour (mL/hour). |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose | Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26 | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose | Predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1, 12, and 26 | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. | hours*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. Here, number of participants were included who were evaluable for the assessment. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. Here, number of participants were included who were evaluable for the assessment. | hours*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose | Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. | hours | MEDIAN |
| SECONDARY | Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose | Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. Here, number of participants were included who were evaluable for the assessment. | hours | MEDIAN |
| SECONDARY | Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. Here, number of participants were included who were evaluable for the assessment. | hours | MEDIAN |
| SECONDARY | Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. Here, number of participants were included who were evaluable for the assessment. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma | Blood samples were taken at specific time points from pre-dose to 72 hours post last dose of Padsevonil (PSL) (Treatment Period 1 and 2); from pre-dose to 120 hours post last dose of PSL (Treatment Period 3) | The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. As per the planned analysis, data was summarized by treatment periods. Here, number of participants were included who were evaluable for the assessment. | mL/hour | GEOMETRIC_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose | Padsevonil (Period 1) (PK-PPS) | 366.6 | Geometric Coefficient of Variation 38.8 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose | Padsevonil (Period 2) (PK-PPS) | 385.3 | Geometric Coefficient of Variation 40.9 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose | Padsevonil and Erythromycin (Period 3b) (PK-PPS) | 697.4 | Geometric Coefficient of Variation 46.9 | ng/mL | |
| Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose | Padsevonil (Period 1) (PK-PPS) | 1428 | Geometric Coefficient of Variation 40.7 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose | Padsevonil (Period 2) (PK-PPS) | 1571 | Geometric Coefficient of Variation 41.8 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose | Padsevonil and Erythromycin (Period 3b) (PK-PPS) | 2576 | Geometric Coefficient of Variation 47.0 | hours*ng/mL | |
| Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses | Padsevonil (Period 1) (PK-PPS) | 475.0 | Geometric Coefficient of Variation 38.4 | ng/mL | |
| Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses | Padsevonil (Period 2) (PK-PPS) | 473.9 | Geometric Coefficient of Variation 43.7 | ng/mL | |
| Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses | Padsevonil and Erythromycin (Period 3b) (PK-PPS) | 1010 | Geometric Coefficient of Variation 45.7 | ng/mL | |
| Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses | Padsevonil (Period 1) (PK-PPS) | 2049 | Geometric Coefficient of Variation 41.1 | hours*ng/mL |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Padsevonil (Period 1) | STARTED | Padsevonil and/or Erythromycin | 28 | |
| Padsevonil (Period 1) | COMPLETED | Padsevonil and/or Erythromycin | 28 | |
| Padsevonil (Period 1) | NOT COMPLETED | Padsevonil and/or Erythromycin | 0 | |
| Padsevonil (Period 2) | STARTED | Padsevonil and/or Erythromycin | 28 | |
| Padsevonil (Period 2) | COMPLETED | Padsevonil and/or Erythromycin | 27 | |
| Padsevonil (Period 2) | NOT COMPLETED | Padsevonil and/or Erythromycin | 1 | |
| Erythromycin (Period 3a) | STARTED | Padsevonil and/or Erythromycin | 27 | |
| Erythromycin (Period 3a) | COMPLETED | Padsevonil and/or Erythromycin | 27 | |
| Erythromycin (Period 3a) | NOT COMPLETED | Padsevonil and/or Erythromycin | 0 | |
| Padsevonil and Erythromycin (Period 3b) | STARTED | Padsevonil and/or Erythromycin | 27 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events40
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 | Medical device site reaction | General disorders | Padsevonil (Period 1+2) (FAS) | 5 | 28 | 5 |
| other | Medical device site reaction | General disorders | Erythromycin (Period 3a) (FAS) | 0 | 27 | 0 |
| other | Medical device site reaction | General disorders | Padsevonil and Erythromycin (Period 3b) (FAS) | 7 | 27 | 7 |
| other | Medical device site reaction | General disorders | Erythromycin (Period 3c) (FAS) | 0 | 26 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Padsevonil (Period 1+2) (FAS) | 3 | 28 | 3 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Erythromycin (Period 3a) (FAS) | 0 | 27 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Padsevonil and Erythromycin (Period 3b) (FAS) | 0 | 27 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Erythromycin (Period 3c) (FAS) | 0 | 26 | 0 |
| other | Dizziness | Nervous system disorders | Padsevonil (Period 1+2) (FAS) | 18 | 28 | 27 |
| other | Dizziness | Nervous system disorders | Erythromycin (Period 3a) (FAS) | 0 | 27 | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Padsevonil (Period 1+2) (FAS) | 0 | 28 |
| Total, all-cause mortality | Erythromycin (Period 3a) (FAS) | 0 | 27 |
| Total, all-cause mortality | Padsevonil and Erythromycin (Period 3b) (FAS) | 0 | 27 |
| Total, all-cause mortality | Erythromycin (Period 3c) (FAS) | 0 | 26 |
| Total, other adverse events | Padsevonil (Period 1+2) (FAS) | 28 | 28 |
| Total, other adverse events | Erythromycin (Period 3a) (FAS) | 0 | 27 |
| Total, other adverse events | Padsevonil and Erythromycin (Period 3b) (FAS) | 25 | 27 |
| Total, other adverse events | Erythromycin (Period 3c) (FAS) | 2 | 26 |
| Total, serious adverse events | Padsevonil (Period 1+2) (FAS) | 0 | 28 |
| Total, serious adverse events | Erythromycin (Period 3a) (FAS) | 0 | 27 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38932723 | 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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GET https://conductscience.org/api/trials/v1/NCT03480243/registered?page=2