CClinicalTrials.gg
Sign In
CompletedNCT03480243Updated Jul 12, 2021Results posted

Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil

A Phase 1 interventional study of Padsevonil (UCB0942) and Erythromycin in Pharmacokinetics, sponsored by UCB Biopharma S.P.R.L.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by UCB Biopharma S.P.R.L. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.

02

Conditions studied

  • Pharmacokinetics

Keywords

  • Padsevonil
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Study participant is male or female and between 18 and 55 years of age (inclusive)
  • Study participant is of a body weight of at least 50 kg for males and 45 kg for females, as determined by a body mass index (BMI) between 18 and 30 kg/m\^2
  • Female study participants use an efficient form of contraception for the duration of the study (unless menopausal). Hormonal contraception may be susceptible to an interaction with the Investigational Medicinal Product (IMP), which may reduce the efficacy of the contraception method. The potential for reduced efficacy of any hormonal contraception methods requires that a barrier method (preferably male condom) also be used
  • Study participant has clinical laboratory test results within the local reference ranges or values are considered as not clinically relevant by the investigator and approved by the UCB Study Physician
  • Study participant has Blood Pressure (BP) and pulse rate within normal range in supine position after 10 minutes of rest
  • Male study participant agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive (condom plus spermicide) AND that the respective partner will use an additional efficient contraceptive method

Exclusion criteria

Exclusion Criteria:

  • Study participant has previously received Investigational Medicinal Product (IMP) in this study
  • Study participant has participated in another study of an IMP (or a medical device) within the previous 3 months before Screening (or within 5 half-lives for the IMP, whichever is longer) or is currently participating in another study of an IMP (or a medical device)
  • Study participant has a history of drug or alcohol dependency within the previous 6 months or tests positive for alcohol (breath test) and/or drugs of abuse (urine test) at the Screening Visit or at any time during confinement
  • Study participant has made a blood or plasma donation or has had a comparable blood loss (>400 mL) within the last 3 months prior to the Screening Visit
  • Study participant smokes more than 5 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit
  • Study participant is taking any concomitant medication currently or within 2 weeks prior to the first day of dosing with the exception of paracetamol (acetaminophen)
  • Study participant has any clinically relevant Electrocardiogram (ECG) finding at the Screening Visit or confinement
  • Study participant has a history within the last 5 years or present condition of malignancy, with the exception of basal cell carcinoma
  • Female study participant tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Padsevonil and Erythromycin

    Treatment Period 1 (Day 1 to Day 11): * Padsevonil 100 mg twice daily (bid) on Day 1 to Day 4 * Padsevonil 100 mg single dose on Day 5 * 1 week of wash-out (from evening of Day 5 to Day 11) Treatment Period 2 (Day 12 to 22): * Padsevonil 100 mg twice daily (bid) on Day 12 to Day 15 * Padsevonil 100 mg single dose on Day 16 * 1 week of wash-out (from evening of Day 16 to Day 22) Treatment Period 3 (Day 23 to Day 38): * Erythromycin 500 mg twice daily (bid) on Day 23 to Day 25 * Padsevonil 100 mg bid and erythromycin 500 mg bid on Day 26 to Day 32 * Padsevonil 100 mg single dose on Day 33 * Erythromycin 500 mg twice daily (bid) on Day 33 to Day 36 * Erythromycin 500 mg single dose on Day 37

    Drug: Padsevonil (UCB0942) · Drug: Erythromycin

Interventions

  • DrugPadsevonil (UCB0942)

    * Pharmaceutical Form: film-coated tablet * Route of Administration: Oral use

  • DrugErythromycin

    * Pharmaceutical Form: film-coated tablet * Route of Administration: Oral use

05

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose

    Cmax: The maximum observed plasma concentration of padsevonil for single dose . Cmax was expressed in nanograms per milliliter (ng/mL).

    Time frame: 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

  2. Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose

    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).

    Time frame: 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

  3. Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses

    Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL).

    Time frame: 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)

  4. Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses

    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).

    Time frame: 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)

Secondary outcomes

  1. Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose

    Tmax: The time of maximum plasma concentration of padsevonil for single dose. Tmax was expressed in hours (h).

    Time frame: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

  2. Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose

    Cmin: The minimum observed plasma concentration of padsevonil for single dose. Cmin was expressed in nanograms per millilitre (ng/mL).

    Time frame: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

  3. Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses

    Tmax: The time of maximum plasma concentration of padsevonil for multiple doses. Tmax was expressed in hours (h).

    Time frame: 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)

  4. Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma

    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).

    Time frame: 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)

  5. Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses

    Ctrough: The predose observed plasma concentration of padsevonil for multiple doses. Ctrough was expressed in nanograms per millilitre (ng/mL).

    Time frame: 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)

  6. Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma

    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).

    Time frame: 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)

  7. Apparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma

    lambdaz: The apparent elimination rate constant of padsevonil for multiple doses in plasma. Lambdaz was expressed in liters per hour (l/hour).

    Time frame: 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)

  8. Maximum Observed Plasma Concentration (Cmax) of Padsevonil Metabolites (1 and 2) for Single Dose

    Cmax: The maximum plasma concentration of padsevonil metabolites (1 and 2) for single dose. Cmax was expressed in nanograms per milliliter (ng/mL).

    Time frame: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

  9. Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil Metabolites (1 and 2) for Single Dose

    AUC(0-12): The area under the plasma concentration-time curve from time zero to 12 hours of padsevonil metabolites (1 and 2) for single dose. AUC(0-12) was expressed in hours times nanograms per milliliter (hours\*ng/mL).

    Time frame: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

  10. Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil Metabolites (1 and 2) for Multiple Doses

    AUCtau: The area under the plasma concentration-time curve over a dosing interval (12 hours) of padsevonil metabolites (1 and 2) for multiple doses. AUCtau was expressed in hours times nanograms per milliliter (hours\*ng/mL).

    Time frame: 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)

  11. Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil Metabolites (1 and 2) for Multiple Doses

    Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil metabolites (1 and 2) for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL).

    Time frame: 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)

  12. Metabolite-to-parent Ratio for Cmax of Padsevonil Metabolites (1 and 2) in Plasma

    Metabolite-to-parent ratio calculated as: Cmax of padsevonil metabolites (1 and 2) divided by Cmax of padsevonil following a single dose in plasma. Metabolite-to-parent ratio for Cmax was expressed as ratio.

    Time frame: Blood samples were taken at specific time points from pre-dose to 12 hours post dose of Padsevonil for each Treatment Period

  13. Metabolite-to-parent Ratio for AUC(0-12) of Padsevonil Metabolites (1 and 2) in Plasma

    Metabolite-to-parent ratio calculated as: AUC(0-12)of padsevonil metabolites (1 and 2) divided by AUC(0-12) of padsevonil following a single dose in plasma. Metabolite-to-parent ratio for AUC(0-12) was expressed as ratio.

    Time frame: Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period

  14. Metabolite-to-parent Ratio for AUCtau of Padsevonil Metabolites (1 and 2) in Plasma

    Metabolite-to-parent ratio calculated as: AUCtau of padsevonil metabolites (1 and 2) divided by AUCtau of padsevonil following multiple dosing in plasma. Metabolite-to-parent ratio for AUCtau was expressed as ratio.

    Time frame: 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)

  15. Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Single Dose in Urine

    CLr: The renal clearance of padsevonil and its metabolites (1 and 2) for single dose in urine. CLr was expressed in milliliters per hour (mL/hour).

    Time frame: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

  16. Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Multiple Doses in Urine

    CLr: The renal clearance of padsevonil and its metabolites (1 and 2) for multiple doses in urine. CLr was expressed in milliliters per hour (mL/hour).

    Time frame: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

  17. Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose

    Ae: The cumulative amount of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for single dose. Ae was expressed in milligrams (mg).

    Time frame: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

  18. Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses

    Ae: The cumulative amount of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for multiple doses. Ae was expressed in milligrams (mg).

    Time frame: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

  19. Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose

    fe: The fraction of padsevonil or metabolites (1, 2, and 3) excreted into the urine for single dose. fe was expressed in percentage (%).

    Time frame: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

  20. Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses

    fe: The fraction of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for multiple doses. fe was expressed in percentage (%).

    Time frame: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

  21. Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Single Dose

    CLform: The formation clearance of padsevonil metabolites (1, 2, and 3) in the urine for single dose. CLform was expressed in milliliters per hour (mL/hour).

    Time frame: Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period

  22. Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Multiple Doses

    CLform: The formation clearance of padsevonil metabolites (1, 2, and 3) in the urine for multiple doses. CLform was expressed in milliliters per hour (mL/hour).

    Time frame: Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3

  23. Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study

    An SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.

    Time frame: From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days )

  24. Percentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study

    Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of UP0057 IMP, or events in which severity worsened on or after the date of first dose of UP0057 study medication.

    Time frame: From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days )

06

Results

Posted Jul 12, 2021

Participant flow

The study started to enroll patients in March 2018 and concluded in August 2018.

Padsevonil (Period 1)
Participant flow — Padsevonil (Period 1)
MilestonePadsevonil and/or Erythromycin
Started28
Completed28
Not completed0
Padsevonil (Period 2)
Participant flow — Padsevonil (Period 2)
MilestonePadsevonil and/or Erythromycin
Started28
Completed27
Not completed1
Withdrew: Consent withdrawal by subject1
Erythromycin (Period 3a)
Participant flow — Erythromycin (Period 3a)
MilestonePadsevonil and/or Erythromycin
Started27
Completed27
Not completed0
Padsevonil and Erythromycin (Period 3b)
Participant flow — Padsevonil and Erythromycin (Period 3b)
MilestonePadsevonil and/or Erythromycin
Started27
Completed26
Not completed1
Withdrew: Un-cooperative behaviour1
Erythromycin (Period 3c)
Participant flow — Erythromycin (Period 3c)
MilestonePadsevonil and/or Erythromycin
Started26
Completed26
Not completed0

Outcome measures

PrimaryMaximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose

Cmax: The maximum observed plasma concentration of padsevonil for single dose . Cmax was expressed in nanograms per milliliter (ng/mL).

Time frame:
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
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose
ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Maximum Observed Plasma Concentration (Cmax) of Padsevonil for Single Dose366.6 ± 38.8385.3 ± 40.9697.4 ± 46.9
Statistical analysis
  • Padsevonil (Period 1) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Cmax estimate ratio: 1.90 · 90% CI 1.59 to 2.27
  • Padsevonil (Period 2) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Cmax estimate ratio: 1.81 · 90% CI 1.51 to 2.16
PrimaryArea Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose

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).

Time frame:
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
Reported as:
Geometric mean · hours*ng/mL
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose
hours*ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil for Single Dose1428 ± 40.71571 ± 41.82576 ± 47.0
Statistical analysis
  • Padsevonil (Period 1) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Auc estimate ratio: 1.80 · 90% CI 1.50 to 2.17
  • Padsevonil (Period 2) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Auc estimate ratio: 1.64 · 90% CI 1.36 to 1.97
PrimaryMaximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses

Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL).

Time frame:
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)
Reported as:
Geometric mean · ng/mL
Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses
ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil for Multiple Doses475.0 ± 38.4473.9 ± 43.71010 ± 45.7
Statistical analysis
  • Padsevonil (Period 1) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Cmax,ss estimate ratio: 2.13 · 90% CI 1.77 to 2.55
  • Padsevonil (Period 2) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Cmax,ss estimate ratio: 2.13 · 90% CI 1.78 to 2.56
PrimaryArea Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses

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).

Time frame:
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)
Reported as:
Geometric mean · hours*ng/mL
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses
hours*ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil for Multiple Doses2049 ± 41.12274 ± 47.15073 ± 55.9
Statistical analysis
  • Padsevonil (Period 1) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Auctau estimate ratio: 2.48 · 90% CI 2.02 to 3.03
  • Padsevonil (Period 2) (PK-PPS) vs Padsevonil and Erythromycin (Period 3b) (PK-PPS) · ANOVA · Auctau estimate ratio: 2.23 · 90% CI 1.82 to 2.73
SecondaryTime of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose

Tmax: The time of maximum plasma concentration of padsevonil for single dose. Tmax was expressed in hours (h).

Time frame:
Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period
Reported as:
Median · hours
Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose
hoursPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Single Dose3.000 (1.00 to 4.05)1.500 (0.500 to 4.00)1.500 (0.750 to 3.02)
SecondaryMinimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose

Cmin: The minimum observed plasma concentration of padsevonil for single dose. Cmin was expressed in nanograms per millilitre (ng/mL).

Time frame:
Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period
Reported as:
Geometric mean · ng/mL
Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose
ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Minimum Observed Plasma Concentration (Cmin) of Padsevonil for Single Dose2.857 ± 100.95.643 ± 147.84.286 ± 172.5
SecondaryTime of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses

Tmax: The time of maximum plasma concentration of padsevonil for multiple doses. Tmax was expressed in hours (h).

Time frame:
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)
Reported as:
Median · hours
Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses
hoursPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Time of Maximum Plasma Concentration (Tmax) of Padsevonil for Multiple Doses1.750 (0.500 to 4.00)1.500 (0.500 to 4.00)2.000 (0.750 to 4.00)
SecondaryApparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma

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).

Time frame:
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)
Reported as:
Median · hours
Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma
hoursPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Apparent Terminal Elimination Half-life at Steady-state (t1/2,ss) of Padsevonil for Multiple Doses in Plasma6.465 (4.44 to 11.0)6.649 (2.04 to 14.3)8.548 (5.54 to 26.9)
SecondaryPredose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses

Ctrough: The predose observed plasma concentration of padsevonil for multiple doses. Ctrough was expressed in nanograms per millilitre (ng/mL).

Time frame:
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)
Reported as:
Geometric mean · ng/mL
Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses
ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Predose Observed Plasma Concentration (Ctrough) of Padsevonil for Multiple Doses57.03 ± 69.068.57 ± 85.1182.6 ± 95.5
SecondaryApparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma

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).

Time frame:
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)
Reported as:
Geometric mean · mL/hour
Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma
mL/hourPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Apparent Total Clearance at Steady-state (CL/Fss) of Padsevonil for Multiple Doses in Plasma48810 ± 41.143970 ± 47.119710 ± 55.9
SecondaryApparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma

lambdaz: The apparent elimination rate constant of padsevonil for multiple doses in plasma. Lambdaz was expressed in liters per hour (l/hour).

Time frame:
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)
Reported as:
Geometric mean · l\hour
Apparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma
l\hourPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Apparent Elimination Rate Constant (Lambdaz) of Padsevonil for Multiple Doses in Plasma0.1049 ± 27.90.1006 ± 36.20.07975 ± 34.5
SecondaryMaximum Observed Plasma Concentration (Cmax) of Padsevonil Metabolites (1 and 2) for Single Dose

Cmax: The maximum plasma concentration of padsevonil metabolites (1 and 2) for single dose. Cmax was expressed in nanograms per milliliter (ng/mL).

Time frame:
Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) of Padsevonil Metabolites (1 and 2) for Single Dose
ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 1166.6 ± 29.1158.7 ± 34.5189.5 ± 29.8
Metabolite 2110.5 ± 33.494.47 ± 44.2108.3 ± 49.6
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil Metabolites (1 and 2) for Single Dose

AUC(0-12): The area under the plasma concentration-time curve from time zero to 12 hours of padsevonil metabolites (1 and 2) for single dose. AUC(0-12) was expressed in hours times nanograms per milliliter (hours\*ng/mL).

Time frame:
Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period
Reported as:
Geometric mean · hours*ng/mL
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC(0-12)) of Padsevonil Metabolites (1 and 2) for Single Dose
hours*ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 1828.3 ± 24.2824.3 ± 25.5905.6 ± 29.7
Metabolite 2596.5 ± 39.0534.4 ± 43.9599.5 ± 49.5
SecondaryArea Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil Metabolites (1 and 2) for Multiple Doses

AUCtau: The area under the plasma concentration-time curve over a dosing interval (12 hours) of padsevonil metabolites (1 and 2) for multiple doses. AUCtau was expressed in hours times nanograms per milliliter (hours\*ng/mL).

Time frame:
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)
Reported as:
Geometric mean · hours*ng/mL
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (12 Hours) (AUCtau) of Padsevonil Metabolites (1 and 2) for Multiple Doses
hours*ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 11748 ± 35.11993 ± 40.82625 ± 46.1
Metabolite 2775.1 ± 37.4813.1 ± 40.5799.0 ± 38.5
SecondaryMaximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil Metabolites (1 and 2) for Multiple Doses

Cmax, ss: The maximum observed steady-state plasma concentration of padsevonil metabolites (1 and 2) for multiple doses. Cmax, ss was expressed in nanograms per millilitre (ng/mL).

Time frame:
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)
Reported as:
Geometric mean · ng/mL
Maximum Observed Steady-state Plasma Concentration (Cmax, ss) of Padsevonil Metabolites (1 and 2) for Multiple Doses
ng/mLPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 1232.3 ± 27.1258.3 ± 32.3310.3 ± 46.0
Metabolite 2118.6 ± 29.3113.3 ± 36.8101.8 ± 37.1
SecondaryMetabolite-to-parent Ratio for Cmax of Padsevonil Metabolites (1 and 2) in Plasma

Metabolite-to-parent ratio calculated as: Cmax of padsevonil metabolites (1 and 2) divided by Cmax of padsevonil following a single dose in plasma. Metabolite-to-parent ratio for Cmax was expressed as ratio.

Time frame:
Blood samples were taken at specific time points from pre-dose to 12 hours post dose of Padsevonil for each Treatment Period
Reported as:
Geometric mean · ratio
Metabolite-to-parent Ratio for Cmax of Padsevonil Metabolites (1 and 2) in Plasma
ratioPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 10.4544 ± 40.60.4119 ± 45.50.2717 ± 49.5
Metabolite 20.3015 ± 66.80.2452 ± 77.10.1552 ± 94.3
SecondaryMetabolite-to-parent Ratio for AUC(0-12) of Padsevonil Metabolites (1 and 2) in Plasma

Metabolite-to-parent ratio calculated as: AUC(0-12)of padsevonil metabolites (1 and 2) divided by AUC(0-12) of padsevonil following a single dose in plasma. Metabolite-to-parent ratio for AUC(0-12) was expressed as ratio.

Time frame:
Blood samples were taken at specific time points from pre-dose to 12 hours post first dose of Padsevonil for each Treatment Period
Reported as:
Geometric mean · ratio
Metabolite-to-parent Ratio for AUC(0-12) of Padsevonil Metabolites (1 and 2) in Plasma
ratioPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 10.5799 ± 39.70.5246 ± 42.80.3515 ± 48.9
Metabolite 20.4176 ± 70.00.3401 ± 78.70.2327 ± 97.1
SecondaryMetabolite-to-parent Ratio for AUCtau of Padsevonil Metabolites (1 and 2) in Plasma

Metabolite-to-parent ratio calculated as: AUCtau of padsevonil metabolites (1 and 2) divided by AUCtau of padsevonil following multiple dosing in plasma. Metabolite-to-parent ratio for AUCtau was expressed as ratio.

Time frame:
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)
Reported as:
Geometric mean · ratio
Metabolite-to-parent Ratio for AUCtau of Padsevonil Metabolites (1 and 2) in Plasma
ratioPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 10.8533 ± 34.90.8766 ± 38.70.5174 ± 48.2
Metabolite 20.3783 ± 63.40.3576 ± 75.50.1575 ± 88.5
SecondaryRenal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Single Dose in Urine

CLr: The renal clearance of padsevonil and its metabolites (1 and 2) for single dose in urine. CLr was expressed in milliliters per hour (mL/hour).

Time frame:
Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period
Reported as:
Geometric mean · mL/hour
Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Single Dose in Urine
mL/hourPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Padsevonil27.40 ± 54.325.80 ± 73.019.36 ± 60.2
Metabolite 1253.7 ± 47.8283.0 ± 60.1255.0 ± 53.9
Metabolite 217640 ± 19.617630 ± 21.216290 ± 20.7
SecondaryRenal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Multiple Doses in Urine

CLr: The renal clearance of padsevonil and its metabolites (1 and 2) for multiple doses in urine. CLr was expressed in milliliters per hour (mL/hour).

Time frame:
Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3
Reported as:
Geometric mean · mL/hours
Renal Clearance (CLr) of Padsevonil and Metabolites (1 and 2) for Multiple Doses in Urine
mL/hoursPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Padsevonil28.43 ± 58.025.24 ± 59.725.12 ± 56.1
Metabolite 1335.0 ± 50.2325.4 ± 40.8311.4 ± 51.7
Metabolite 219390 ± 24.918530 ± 20.716470 ± 27.6
SecondaryCumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose

Ae: The cumulative amount of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for single dose. Ae was expressed in milligrams (mg).

Time frame:
Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period
Reported as:
Geometric mean · milligrams
Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose
milligramsPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Padsevonil0.03914 ± 57.50.04054 ± 75.00.04987 ± 74.6
Metabolite 10.2101 ± 43.20.2333 ± 52.10.2309 ± 45.8
Metabolite 210.53 ± 42.59.423 ± 45.59.764 ± 53.1
Metabolite 329.11 ± 39.327.44 ± 42.326.09 ± 40.6
SecondaryCumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses

Ae: The cumulative amount of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for multiple doses. Ae was expressed in milligrams (mg).

Time frame:
Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3
Reported as:
Geometric mean · milligrams
Cumulative Amount (Ae) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses
milligramsPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Padsevonil0.05825 ± 57.20.05741 ± 58.60.1274 ± 62.3
Metabolite 10.6188 ± 45.30.6657 ± 45.00.8797 ± 46.8
Metabolite 215.03 ± 45.815.07 ± 46.913.67 ± 41.4
Metabolite 370.83 ± 30.765.30 ± 34.081.36 ± 30.7
SecondaryFraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose

fe: The fraction of padsevonil or metabolites (1, 2, and 3) excreted into the urine for single dose. fe was expressed in percentage (%).

Time frame:
Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period
Reported as:
Geometric mean · percentage excreted
Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Single Dose
percentage excretedPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Padsevonil0.03914 ± 57.50.04054 ± 75.00.04987 ± 74.6
Metabolite 10.2170 ± 43.20.2410 ± 52.10.2385 ± 45.8
Metabolite 210.52 ± 42.59.419 ± 45.59.760 ± 53.1
Metabolite 321.17 ± 39.319.96 ± 42.318.98 ± 40.6
SecondaryFraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses

fe: The fraction of padsevonil and its metabolites (1, 2, and 3) excreted into the urine for multiple doses. fe was expressed in percentage (%).

Time frame:
Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3
Reported as:
Geometric mean · percentage excreted
Fraction (fe) of Padsevonil and Metabolites (1, 2, and 3) Excreted Into the Urine for Multiple Doses
percentage excretedPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Padsevonil0.05825 ± 57.20.05741 ± 58.60.1274 ± 62.3
Metabolite 10.6049 ± 45.60.6700 ± 44.60.8443 ± 45.3
Metabolite 215.02 ± 45.815.06 ± 46.913.15 ± 37.9
Metabolite 351.52 ± 30.747.50 ± 34.056.69 ± 38.0
SecondaryFormation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Single Dose

CLform: The formation clearance of padsevonil metabolites (1, 2, and 3) in the urine for single dose. CLform was expressed in milliliters per hour (mL/hour).

Time frame:
Urine samples were taken 0 to 12 hours post first dose of Padsevonil during each Treatment Period
Reported as:
Geometric mean · mL/hour
Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Single Dose
mL/hourPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 1151.9 ± 67.3153.4 ± 75.892.59 ± 80.8
Metabolite 27365 ± 80.25994 ± 87.83788 ± 107.5
Metabolite 314820 ± 60.512700 ± 59.97367 ± 72.0
SecondaryFormation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Multiple Doses

CLform: The formation clearance of padsevonil metabolites (1, 2, and 3) in the urine for multiple doses. CLform was expressed in milliliters per hour (mL/hour).

Time frame:
Urine samples were taken 0 to 12 hours, 12 to 24 hours,and 24 to 48 hours post last PSL dose during Treatment Period 1 and 2; 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours post last dose of PSL during Treatment Period 3
Reported as:
Geometric mean · mL/h
Formation Clearance (CLform) of Padsevonil Metabolites (1, 2, and 3) in the Urine for Multiple Doses
mL/hPadsevonil (Period 1) (PK-PPS)Padsevonil (Period 2) (PK-PPS)Padsevonil and Erythromycin (Period 3b) (PK-PPS)
Metabolite 1295.3 ± 63.2294.6 ± 58.9166.4 ± 63.8
Metabolite 27331 ± 80.56622 ± 90.92593 ± 93.9
Metabolite 325150 ± 44.720890 ± 48.111170 ± 58.7
SecondaryPercentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study

An SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.

Time frame:
From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days )
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study
percentage of participantsPadsevonil (Period 1+2) (FAS)Erythromycin (Period 3a) (FAS)Padsevonil and Erythromycin (Period 3b) (FAS)Erythromycin (Period 3c) (FAS)
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) During the Study0000
SecondaryPercentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study

Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of UP0057 IMP, or events in which severity worsened on or after the date of first dose of UP0057 study medication.

Time frame:
From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to 48 days )
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study
percentage of participantsPadsevonil (Period 1+2) (FAS)Erythromycin (Period 3a) (FAS)Padsevonil and Erythromycin (Period 3b) (FAS)Erythromycin (Period 3c) (FAS)
Percentage of Participants Experiencing Treatment-Emergent Non-serious Adverse Events (AEs) During the Study10011.196.319.2

Adverse events

Collected over From beginning of the first Treatment Period (Day 1) to the Safety Follow-up Visit (up to Day 48). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Padsevonil (Period 1+2) (FAS)0/28 (0%)0/28 (0%)28/28 (100%)
Erythromycin (Period 3a) (FAS)0/27 (0%)0/27 (0%)0/27 (0%)
Padsevonil and Erythromycin (Period 3b) (FAS)0/27 (0%)0/27 (0%)25/27 (92.6%)
Erythromycin (Period 3c) (FAS)0/26 (0%)0/26 (0%)2/26 (7.7%)
Most frequent other events
Most frequent other events
EventPadsevonil (Period 1+2) (FAS)Erythromycin (Period 3a) (FAS)Padsevonil and Erythromycin (Period 3b) (FAS)Erythromycin (Period 3c) (FAS)
SomnolenceNervous system disorders28/280/2725/270/26
DizzinessNervous system disorders18/280/278/270/26
Medical device site reactionGeneral disorders5/280/277/270/26
Euphoric moodPsychiatric disorders6/280/275/270/26
HeadacheNervous system disorders5/280/270/272/26
Back painMusculoskeletal and connective tissue disorders3/280/270/270/26
ParaesthesiaNervous system disorders2/280/270/270/26
Depressed moodPsychiatric disorders2/280/270/270/26
InsomniaPsychiatric disorders2/280/270/270/26
Dry skinSkin and subcutaneous tissue disorders2/280/270/270/26

Baseline characteristics

Baseline Characteristics refer to the Full Analysis Set (FAS) which consisted of all study participants who have signed the Informed Consent Form (ICF) and received the investigational medicinal product (IMP).

Age, Categorical
Age, Categorical(Participants)Padsevonil and/or Erythromycin
<=18 years0
Between 18 and 65 years28
>=65 years0
Age, Continuous
Age, Continuous(years)Padsevonil and/or Erythromycin
Mean36.7 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)Padsevonil and/or Erythromycin
Female3
Male25
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Padsevonil and/or Erythromycin
Asian2
Black1
White24
Missing1
07

Study locations

1 site
  • Up0057 001
    London, United Kingdom
08

References and documents

Study documents

  • Study protocol · Jan 26, 2018
  • Statistical analysis plan · May 15, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03480243
Lead sponsor
UCB Biopharma S.P.R.L.
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Mar 27, 2018
Primary completion
Aug 2, 2018
Completion
Aug 2, 2018
Results posted
Jul 12, 2021
Last update
Jul 12, 2021

Study contacts

UCB Cares
study director · 001 844 599 2273 (UCB)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

UCB Biopharma S.P.R.L.

Start the discussion