Healthy ParticipantsPhase 1NCT04283136
A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
A Phase 1 study testing Padsevonil type 1 Tablet 200 mg, Padsevonil type 2 Tablet and Padsevonil type 3 Tablet in people with Healthy Participants and Epilepsy, run by UCB Biopharma SRL.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Epilepsy
- What is being tested?
- Padsevonil type 1 Tablet 200 mg, Padsevonil type 2 Tablet and Padsevonil type 3 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2020to 22 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Healthy Participants, Epilepsy
- Being tested
- Padsevonil type 1 Tablet 200 mg, Padsevonil type 2 Tablet, Padsevonil type 3 Tablet, Padsevonil type 4 Tablet, Padsevonil type 5 Tablet
- Keywords
- Phase 1, Padsevonil, Bioavailability, Food effect
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Padsevonil type 1 Tablet 200 mgDrug
- 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.
Padsevonil type 2 TabletDrug
- 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
Padsevonil type 3 TabletDrug
- 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.
Padsevonil type 4 TabletDrug
- 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.
Padsevonil type 5 TabletDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 tablet - part 1 | Active comparator | 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. Receives: Drug: Padsevonil type 1 Tablet 200 mg |
| Type 2 tablet - part 1 | Experimental | 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. Receives: Drug: Padsevonil type 2 Tablet |
| Type 3 tablet - part 1 | Experimental | 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. Receives: Drug: Padsevonil type 3 Tablet |
| Type 4 tablet - part 1 | Experimental | 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. Receives: Drug: Padsevonil type 4 Tablet |
| Type 5 tablet - part 1 | Experimental | 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. Receives: Drug: Padsevonil type 5 Tablet |
| Type 1 tablet - part 2 (2 x 200 mg fasted) | Active comparator | 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. Receives: Drug: Padsevonil type 1 Tablet 200 mg |
| Type 1 tablet - part 2 (2 x 200 mg fed) | Active comparator | 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. Receives: Drug: Padsevonil type 1 Tablet 200 mg |
| Type 1 tablet - part 2 (200 mg fasted) | Active comparator | 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. Receives: Drug: Padsevonil type 1 Tablet 200 mg |
| Type 1 tablet - part 2 (200 mg fed) | Active comparator | 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. Receives: Drug: Padsevonil type 1 Tablet 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: 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 of padsevonil type 1 tablets during part 1
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 2 tablets during part 1
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 3 tablets during part 1
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 4 tablets during part 1
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 5 tablets during part 1
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 1 tablets (400 mg, fasted) during part 2
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 1 tablets (400 mg, fed) during part 2
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 1 tablets (200 mg, fasted) during part 2
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 1 tablets (200 mg, fed) during part 2
AUC: Area under the concentration-time curve from time 0 to infinity
Measured: 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 of padsevonil type 1 tablets during part 1
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 2 tablets during part 1
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 3 tablets during part 1
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 4 tablets during part 1
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 5 tablets during part 1
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 1 tablets (400 mg, fasted) during part 2
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 1 tablets (400 mg, fed) during part 2
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 1 tablets (200 mg, fasted) during part 2
Cmax: Maximum observed plasma concentration
Measured: 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 of padsevonil type 1 tablets (200 mg, fed) during part 2
Cmax: Maximum observed plasma concentration
Measured: 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 (2)
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.
Measured: From Baseline up to Day 35
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
Measured: From Baseline up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start24 Feb 2020
- Primary completion22 May 2020
- Study completion22 May 2020
Why it stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283136
- Sponsor's protocol ID
- UP0081
- Status last verified
- Jun 2020
- First submitted
- 21 Feb 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04283136
- Acronym / sponsor ID
- UP0081
- Conditions
- Healthy Participants, Epilepsy
- Keywords
- Phase 1, Padsevonil, Bioavailability, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
- 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.
| Arm | Type | Receives |
|---|---|---|
| Type 1 tablet - part 1 | Active comparator | Drug: Padsevonil type 1 Tablet 200 mgSubjects will receive a single dose of padsevonil Type 1 tablet in the period defined by the pre-specified sequence they were randomized on to. |
| Type 2 tablet - part 1 | Experimental | Drug: Padsevonil type 2 TabletSubjects will receive a single dose of padsevonil Type 2 tablet in the period defined by the pre-specified sequence they were randomized on to. |
| Type 3 tablet - part 1 | Experimental | Drug: Padsevonil type 3 TabletSubjects will receive a single dose of padsevonil Type 3 tablet in the period defined by the pre-specified sequence they were randomized on to. |
| Type 4 tablet - part 1 | Experimental | Drug: Padsevonil type 4 TabletSubjects will receive a single dose of padsevonil Type 4 tablet in the period defined by the pre-specified sequence they were randomized on to. |
| Type 5 tablet - part 1 | Experimental | Drug: Padsevonil type 5 TabletSubjects will receive a single dose of padsevonil Type 5 tablet in the period defined by the pre-specified sequence they were randomized on to. |
| Type 1 tablet - part 2 (2 x 200 mg fasted) | Active comparator | Drug: Padsevonil type 1 Tablet 200 mgSubjects 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. |
| Type 1 tablet - part 2 (2 x 200 mg fed) | Active comparator | Drug: Padsevonil type 1 Tablet 200 mgSubjects 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. |
| Type 1 tablet - part 2 (200 mg fasted) | Active comparator | Drug: Padsevonil type 1 Tablet 200 mgSubjects 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. |
| Type 1 tablet - part 2 (200 mg fed) | Active comparator | Drug: Padsevonil type 1 Tablet 200 mgSubjects 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Type 1 tablet - part 1, Type 1 tablet - part 2 (2 x 200 mg fasted), Type 1 tablet - part 2 (2 x 200 mg fed), Type 1 tablet - part 2 (200 mg fasted), Type 1 tablet - part 2 (200 mg fed) |
| 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 | Drug | Type 2 tablet - part 1 |
| 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. | Drug | Type 3 tablet - part 1 |
| 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. | Drug | Type 4 tablet - part 1 |
| 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. | Drug | Type 5 tablet - part 1 |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Baseline up to Day 35
Incidence of Serious Adverse Events (SAEs)
Time frame: From Baseline up to Day 35
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Padsevonil type 1 Tablet 200 mg, Padsevonil type 2 Tablet and Padsevonil type 3 Tablet in people with Healthy Participants and Epilepsy, run by UCB Biopharma SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.