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WithdrawnNCT04283136Updated Jun 22, 2020

A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil

A Phase 1 interventional study of Padsevonil type 1 Tablet 200 mg and Padsevonil type 2 Tablet in Healthy Participants and Epilepsy, sponsored by UCB Biopharma SRL. Withdrawn. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-22.

Sponsored by UCB Biopharma SRL · Phase 1, Interventional, and Basic science

Why this study was withdrawn
Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of the study in Part 1, is to evaluate (under fasted conditions) the plasma pharmacokinetics (PK) of padsevonil (PSL) using 4 PSL product variants against a PSL reference tablet and in Part 2, to evaluate the PK of PSL using a PSL reference tablet under fed and fasted conditions at 200 mg and 400 mg.

02

Conditions studied

  • Healthy Participants
  • Epilepsy

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Keywords

  • Phase 1
  • Padsevonil
  • Bioavailability
  • Food effect
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

Browse Epilepsy studies →

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF)
  • Study participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
  • Study participants must have a body weight of at least 50 kg for males and 45 kg for females and body mass index within the range 18 to 35 kg/m2 (inclusive)

  • Study participants who are male or female:

    1. A male participant must agree to use contraception during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period

    2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

      • Not a woman of childbearing potential (WOCBP) OR
      • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days (or 5 terminal half-lives) after the last dose of study medication

Exclusion criteria

Exclusion Criteria:

  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study or a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at Screening
  • Study participant has a history or presence of/significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
  • Study participant has a history or present condition of respiratory or cardiovascular disorders, (eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction)
  • Study participant has had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin, etc) within 2 months prior to the first dose of study medication. In case of uncertainty, the Medical Monitor should be consulted
  • Study participant has participated in another study of an investigational study medication (and/or an investigational device) within the previous 60 days before Screening (or 5 half-lives, whichever is longer) or is currently participating in another study of an investigational study medication (and/or an investigational device)
  • Study participant has made a blood donation or has had a comparable blood loss (>400 mL) within the last 3 months prior to the Screening Visit or has made plasma donation within last month 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Type 1 tablet - part 1

    Subjects will receive a single dose of padsevonil Type 1 tablet in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 1 Tablet 200 mg

  • Experimental
    Type 2 tablet - part 1

    Subjects will receive a single dose of padsevonil Type 2 tablet in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 2 Tablet

  • Experimental
    Type 3 tablet - part 1

    Subjects will receive a single dose of padsevonil Type 3 tablet in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 3 Tablet

  • Experimental
    Type 4 tablet - part 1

    Subjects will receive a single dose of padsevonil Type 4 tablet in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 4 Tablet

  • Experimental
    Type 5 tablet - part 1

    Subjects will receive a single dose of padsevonil Type 5 tablet in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 5 Tablet

  • Active comparator
    Type 1 tablet - part 2 (2 x 200 mg fasted)

    Subjects will receive a single 2 x 200 mg dose of padsevonil Type 1 tablet under fasting conditions in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 1 Tablet 200 mg

  • Active comparator
    Type 1 tablet - part 2 (2 x 200 mg fed)

    Subjects will receive a single 2 x 200 mg dose of padsevonil Type 1 tablet under fed conditions in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 1 Tablet 200 mg

  • Active comparator
    Type 1 tablet - part 2 (200 mg fasted)

    Subjects will receive a single 200 mg dose of padsevonil Type 1 tablet under fasting conditions in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 1 Tablet 200 mg

  • Active comparator
    Type 1 tablet - part 2 (200 mg fed)

    Subjects will receive a single 200 mg dose of padsevonil Type 1 tablet under fed conditions in the period defined by the pre-specified sequence they were randomized on to.

    Drug: Padsevonil type 1 Tablet 200 mg

Interventions

  • DrugPadsevonil type 1 Tablet 200 mg

    * Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 1 tablet in a pre-specified sequence during the Treatment Period.

  • DrugPadsevonil type 2 Tablet

    * Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 2 tablet in a pre-specified sequence during the Treatment Period

  • DrugPadsevonil type 3 Tablet

    * Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 3 tablet in a pre-specified sequence during the Treatment Period.

  • DrugPadsevonil type 4 Tablet

    * Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 4 tablet in a pre-specified sequence during the Treatment Period.

  • DrugPadsevonil type 5 Tablet

    * Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 5 tablet in a pre-specified sequence during the Treatment Period.

06

What researchers measure

Primary outcomes

  1. AUC0-t of padsevonil type 1 tablets during part 1

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  2. AUC0-t of padsevonil type 2 tablets during part 1

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  3. AUC0-t of padsevonil type 3 tablets during part 1

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  4. AUC0-t of padsevonil type 4 tablets during part 1

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  5. AUC0-t of padsevonil type 5 tablets during part 1

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  6. AUC0-t of padsevonil type 1 tablets (2x200 mg, fasted) during part 2

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  7. AUC0-t of padsevonil type 1 tablets (2x200 mg, fed) during part 2

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  8. AUC0-t of padsevonil type 1 tablets (200 mg, fasted) during part 2

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  9. AUC0-t of padsevonil type 1 tablets (200 mg, fed) during part 2

    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  10. AUC of padsevonil type 1 tablets during part 1

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  11. AUC of padsevonil type 2 tablets during part 1

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  12. AUC of padsevonil type 3 tablets during part 1

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  13. AUC of padsevonil type 4 tablets during part 1

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  14. AUC of padsevonil type 5 tablets during part 1

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  15. AUC of padsevonil type 1 tablets (400 mg, fasted) during part 2

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  16. AUC of padsevonil type 1 tablets (400 mg, fed) during part 2

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  17. AUC of padsevonil type 1 tablets (200 mg, fasted) during part 2

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  18. AUC of padsevonil type 1 tablets (200 mg, fed) during part 2

    AUC: Area under the concentration-time curve from time 0 to infinity

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  19. Cmax of padsevonil type 1 tablets during part 1

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  20. Cmax of padsevonil type 2 tablets during part 1

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  21. Cmax of padsevonil type 3 tablets during part 1

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  22. Cmax of padsevonil type 4 tablets during part 1

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  23. Cmax of padsevonil type 5 tablets during part 1

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1.

  24. Cmax of padsevonil type 1 tablets (400 mg, fasted) during part 2

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  25. Cmax of padsevonil type 1 tablets (400 mg, fed) during part 2

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  26. Cmax of padsevonil type 1 tablets (200 mg, fasted) during part 2

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

  27. Cmax of padsevonil type 1 tablets (200 mg, fed) during part 2

    Cmax: Maximum observed plasma concentration

    Time frame: Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

    Time frame: From Baseline up to Day 35

  2. Incidence of Serious Adverse Events (SAEs)

    A Serious Adverse Event (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 Baseline up to Day 35

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04283136
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
Feb 25, 2020
Start date
Feb 24, 2020
Primary completion
May 22, 2020
Completion
May 22, 2020
Last update
Jun 22, 2020

Study contacts

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

Oversight

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

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