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

NCT ID: NCT03480243

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2018-08-02

Brief 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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Padsevonil (UCB0942)

Intervention Type: DRUG

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

Erythromycin

Intervention Type: DRUG

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

Interventions

Padsevonil (UCB0942)

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

Intervention Type: DRUG

Erythromycin

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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

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

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Up0057 001

London, , United Kingdom

Countries

United Kingdom

References

Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9.

Reference Type: DERIVED

PMID: 38932723 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-004694-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0057

Identifier Type: -

Identifier Source: org_study_id