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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283136
Recruitment Status : Suspended (Study recruitment temporarily halted as a precautionary measure due to the COVID-19 pandemic)
First Posted : February 25, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Participants Epilepsy Drug: Padsevonil type 1 Tablet 200 mg Drug: Padsevonil type 2 Tablet Drug: Padsevonil type 3 Tablet Drug: Padsevonil type 4 Tablet Drug: Padsevonil type 5 Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In Part 1 a single oral dose of padsevonil 200 mg for the 4 different product variants and the padsevonil reference tablet will be administered to all subjects in the fasted state in a randomized 5-way crossover design. In order to explore the food interaction with padsevonil, in Part 2 a single oral dose of a padsevonil reference tablet at dose levels of 200 mg and 400 mg (2x 200mg tablets) will be administered to all subjects in the fasted and fed state in a randomized 4-way crossover study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Randomized, Single-Dose, 2-Part Crossover Study in Healthy Study Participants to Evaluate the Relative Bioavailability of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
  • 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.


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
  • 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


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
  • 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.


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
  • 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.


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
  • 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.


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
  • 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.


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
  • 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.


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
  • 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.


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
  • 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.





Primary Outcome Measures :
  1. AUC0-t of padsevonil type 1 tablets during part 1 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  2. AUC0-t of padsevonil type 2 tablets during part 1 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  3. AUC0-t of padsevonil type 3 tablets during part 1 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  4. AUC0-t of padsevonil type 4 tablets during part 1 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  5. AUC0-t of padsevonil type 5 tablets during part 1 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  6. AUC0-t of padsevonil type 1 tablets (2x200 mg, fasted) during part 2 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  7. AUC0-t of padsevonil type 1 tablets (2x200 mg, fed) during part 2 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  8. AUC0-t of padsevonil type 1 tablets (200 mg, fasted) during part 2 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  9. AUC0-t of padsevonil type 1 tablets (200 mg, fed) during part 2 [ 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. ]
    AUC(0-t): Area under the plasma concentration-time curve from time zero to time t

  10. AUC of padsevonil type 1 tablets during part 1 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  11. AUC of padsevonil type 2 tablets during part 1 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  12. AUC of padsevonil type 3 tablets during part 1 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  13. AUC of padsevonil type 4 tablets during part 1 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  14. AUC of padsevonil type 5 tablets during part 1 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  15. AUC of padsevonil type 1 tablets (400 mg, fasted) during part 2 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  16. AUC of padsevonil type 1 tablets (400 mg, fed) during part 2 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  17. AUC of padsevonil type 1 tablets (200 mg, fasted) during part 2 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  18. AUC of padsevonil type 1 tablets (200 mg, fed) during part 2 [ 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. ]
    AUC: Area under the concentration-time curve from time 0 to infinity

  19. Cmax of padsevonil type 1 tablets during part 1 [ 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. ]
    Cmax: Maximum observed plasma concentration

  20. Cmax of padsevonil type 2 tablets during part 1 [ 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. ]
    Cmax: Maximum observed plasma concentration

  21. Cmax of padsevonil type 3 tablets during part 1 [ 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. ]
    Cmax: Maximum observed plasma concentration

  22. Cmax of padsevonil type 4 tablets during part 1 [ 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. ]
    Cmax: Maximum observed plasma concentration

  23. Cmax of padsevonil type 5 tablets during part 1 [ 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. ]
    Cmax: Maximum observed plasma concentration

  24. Cmax of padsevonil type 1 tablets (400 mg, fasted) during part 2 [ 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. ]
    Cmax: Maximum observed plasma concentration

  25. Cmax of padsevonil type 1 tablets (400 mg, fed) during part 2 [ 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. ]
    Cmax: Maximum observed plasma concentration

  26. Cmax of padsevonil type 1 tablets (200 mg, fasted) during part 2 [ 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. ]
    Cmax: Maximum observed plasma concentration

  27. Cmax of padsevonil type 1 tablets (200 mg, fed) during part 2 [ 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. ]
    Cmax: Maximum observed plasma concentration


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From Baseline up to Day 35 ]
    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.

  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: From Baseline up to Day 35 ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283136


Locations
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United States, Texas
Up0081 001
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04283136    
Other Study ID Numbers: UP0081
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Phase 1
Padsevonil
Bioavailability
Food effect
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases