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

NCT ID: NCT04283136

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2020-05-22

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.

Conditions

Healthy Participants; Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Padsevonil type 1 Tablet 200 mg

Intervention Type: DRUG

• 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.

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.

Group Type: EXPERIMENTAL

Padsevonil type 2 Tablet

Intervention Type: DRUG

• 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

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.

Group Type: EXPERIMENTAL

Padsevonil type 3 Tablet

Intervention Type: DRUG

• 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.

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.

Group Type: EXPERIMENTAL

Padsevonil type 4 Tablet

Intervention Type: DRUG

• 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.

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.

Group Type: EXPERIMENTAL

Padsevonil type 5 Tablet

Intervention Type: DRUG

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Padsevonil type 1 Tablet 200 mg

Intervention Type: DRUG

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Padsevonil type 1 Tablet 200 mg

Intervention Type: DRUG

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Padsevonil type 1 Tablet 200 mg

Intervention Type: DRUG

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Padsevonil type 1 Tablet 200 mg

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Other Identifiers

UP0081

Identifier Type: -

Identifier Source: org_study_id