A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants

NCT ID: NCT04126343

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2020-05-22

Brief Summary

The purpose of the study is to evaluate the effects on cardiac repolarization of high-dose padsevonil (PSL) in comparison to placebo in healthy study participants.

Conditions

Healthy Study Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Padsevonil

Study participants randomized to this arm will receive assigned doses of padsevonil twice daily. On Day 8 padsevonil will be administered in the morning, and placebo will administered in the evening.

Group Type: EXPERIMENTAL

Padsevonil

Intervention Type: DRUG

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive padsevonil in a pre-specified dosing sequence during the Treatment Period

Placebo

Intervention Type: DRUG

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding

Placebo

Study participants randomized to this arm will receive placebo twice daily to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding

Moxifloxacin

Study participants randomized to this arm will receive padsevonil-placebo twice daily. On Day 8 placebo will be administered in the morning, and moxifloxacin will administered in the evening.

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive moxifloxacin once during the Treatment Period

Placebo

Intervention Type: DRUG

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding

Interventions

Padsevonil

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive padsevonil in a pre-specified dosing sequence during the Treatment Period

Intervention Type: DRUG

Moxifloxacin

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive moxifloxacin once during the Treatment Period

Intervention Type: DRUG

Placebo

• Pharmaceutical form: Film-coated tablet
• Route of administration: Oral use
• Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding

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)
• Participant who is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• Body weight of at least 50 kilogram (kg) (males) or 45 kg (females) and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)
• Male and/or female:

A male study participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of study medication 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 one 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 90 days after the last dose of study medication

Exclusion Criteria

• Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol or history of tendon pathology secondary to use of quinolone antibiotics
• Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
• Participant has a present condition of respiratory or cardiovascular disorders, eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction
• Past or intended use of over-the-counter (OTC) or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing.
• 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
• Participant has previously received padsevonil (PSL) in this or any other study
• Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline. Participant has an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any participant with any of the following findings will be excluded:

1. QT interval corrected for heart rate using the Fridericia method (QTcF) ≥450 ms (on mean of triplicate ECG recordings);

2. Other conduction abnormalities (defined as PR interval >220 ms);

3. QRS interval >109 ms;

4. Any rhythm other than sinus rhythm;

5. Any history of Wolff-Parkinson-White Syndrome, Brugada Syndrome, unexplained syncope, or ventricular tachycardia;

6. Family history of QTc prolongation or of unexplainable sudden death at <50 years of age

• Participant has made a blood or plasma donation or has had a comparable blood loss (>450 mL) within 30 days prior to the Screening Visit. Blood donation during the study is not permitted

• 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

Up0050 001

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002797-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0050

Identifier Type: -

Identifier Source: org_study_id