Healthy Study ParticipantsPhase 1NCT04126343
A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
A Phase 1 study testing Padsevonil and Moxifloxacin in people with Healthy Study Participants, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants
- What is being tested?
- Padsevonil and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2019to 22 May 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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:
- QT interval corrected for heart rate using the Fridericia method (QTcF) ≥450 ms (on mean of triplicate ECG recordings);
- Other conduction abnormalities (defined as PR interval >220 ms);
- QRS interval >109 ms;
- Any rhythm other than sinus rhythm;
- Any history of Wolff-Parkinson-White Syndrome, Brugada Syndrome, unexplained syncope, or ventricular tachycardia;
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Placebo-Controlled, 3 Treatment Period Crossover Study to Assess the Effect of Padsevonil on Cardiac Repolarization (QTc Interval) (Using Moxifloxacin as a Positive Control) in Healthy Study Participants
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
- Being tested
- Padsevonil, Moxifloxacin, Placebo
- Keywords
- Healthy study participants, Padsevonil, Moxifloxacin, Cardiac repolarization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PadsevonilDrug
- 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
MoxifloxacinDrug
- Pharmaceutical form: Film-coated tablet
- Route of administration: Oral use
- Study participants will receive moxifloxacin once during the Treatment Period
PlaceboDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Padsevonil | Experimental | 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. Receives: Drug: Padsevonil; Drug: Placebo |
| Placebo | Placebo comparator | Study participants randomized to this arm will receive placebo twice daily to maintain the blinding. Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | 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. Receives: Drug: Moxifloxacin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
Placebo-corrected change from Baseline in corrected QT interval (QTc), based on Fridericia's correction (QTcF) method (ΔΔQTcF) evaluated during the Target Dose Day of the padsevonil and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Secondary outcomes (18)
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
Placebo-corrected change from Baseline in corrected QT interval (QTc), based on Fridericia's correction (QTcF) method (ΔΔQTcF) evaluated during the Target Dose Day of the moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Placebo-corrected change from Baseline in HR, (ΔΔHR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Placebo-corrected change from Baseline in HR, (ΔΔHR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected Change From Baseline for PR Interval on Day 1
Placebo-corrected change from Baseline in PR, (ΔΔPR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Placebo-corrected Change From Baseline for PR Interval on Day 8
Placebo-corrected change from Baseline in PR, (ΔΔPR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Placebo-corrected change from Baseline for QRS interval, (ΔΔQRS) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Placebo-corrected change from Baseline for QRS interval, (ΔΔQRS) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Measured: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Number of Participants with treatment-emergent changes of electrocardiogram waveforms as T-waves and U-waves. If a given morphology occurs multiple times at a given time point, that occurrence was only counted 1 time for that time point. If more than 1 morphology type was observed at a given time point, both morphology types were counted. A subject can appear in more than 1 category.
Measured: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Change From Baseline in QTcF Evaluated at Drug-specific Tmax for Padsevonil
Change from Baseline in QTcF (ΔQTcF) evaluated at drug-specific tmax (Δtmax) for padsevonil, using an analysis of variance (ANOVA) mixed-effect model.
Measured: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Change From Baseline in QTcF Evaluated at Drug-specific Tmax for Metabolite 1
Change from Baseline in QTcF (ΔQTcF) evaluated at drug-specific tmax (Δtmax) for metabolite 1, using an analysis of variance (ANOVA) mixed-effect model.
Measured: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Change From Baseline in QTcF Evaluated at Drug-Specific Tmax for Metabolite 2
Change from Baseline in QTcF (ΔQTcF) evaluated at drug-specific tmax (Δtmax) for metabolite 2, using an analysis of variance (ANOVA) mixed-effect model.
Measured: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Maximum Observed Plasma Concentration at Steady State (Cmax, ss) for Padsevonil
Cmax,ss: Maximum observed plasma concentration of padsevonil at steady state.
Measured: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Time of Observed Maximum Concentration (Tmax) at Steady State for Padsevonil
tmax: Time of observed maximum plasma concentration at steady state.
Measured: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Area Under the Plasma Concentration Time Curve (AUCtau) at Steady State for Padsevonil
AUCtau: Area under the plasma concentration time curve over a dosing interval at steady state.
Measured: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Percentage of Participants With Adverse Events From Baseline to Safety Follow-up (up to Day 67)
An Adverse Event is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: From Baseline to Safety Follow-up (up to Day 67)
Percentage of Participants With Serious Adverse Events From Baseline to Safety Follow-up (up to Day 67)
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 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 to Safety Follow-up (up to Day 67)
Percentage of Participants With Treatment Related Adverse Events From Baseline to Safety Follow-up (up to Day 67)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Baseline to Safety Follow-up (up to Day 67)
Percentage of Participants With Adverse Events Leading to Discontinuation of the Study From Baseline to Safety Follow-up (up to Day 67)
An Adverse Event is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Measured: From Baseline to Safety Follow-up (up to Day 67)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start23 Oct 2019
- 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- 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
- NCT04126343
- Sponsor's protocol ID
- UP0050
- Other IDs
- 2019-002797-31, 2019
- Status last verified
- May 2021
- First submitted
- 11 Oct 2019
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Placebo-Controlled, 3 Treatment Period Crossover Study to Assess the Effect of Padsevonil on Cardiac Repolarization (QTc Interval) (Using Moxifloxacin as a Positive Control) in Healthy Study Participants
- ClinicalTrials.gov ID
- NCT04126343
- Acronym / sponsor ID
- UP0050
- Conditions
- Healthy Study Participants
- Keywords
- Healthy study participants, Padsevonil, Moxifloxacin, Cardiac repolarization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
- Enrolment
- 54 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Posted 18 Jun 2021
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 is to evaluate the effects on cardiac repolarization of high-dose padsevonil (PSL) in comparison to placebo in healthy study participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Padsevonil | Experimental | Drug: Padsevonil, Drug: PlaceboStudy 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. |
| Placebo | Placebo comparator | Drug: PlaceboStudy participants randomized to this arm will receive placebo twice daily to maintain the blinding. |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin, Drug: PlaceboStudy 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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* 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 | Drug | Padsevonil |
| Moxifloxacin* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use * Study participants will receive moxifloxacin once during the Treatment Period | Drug | Moxifloxacin |
| 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 | Drug | Moxifloxacin, Padsevonil, Placebo |
Primary outcome
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
Time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected change from Baseline in corrected QT interval (QTc), based on Fridericia's correction (QTcF) method (ΔΔQTcF) evaluated during the Target Dose Day of the padsevonil and placebo Treatment Periods, using linear mixed-effects model analysis.
18 secondary outcomes
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
Time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Time frame: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Time frame: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected Change From Baseline for PR Interval on Day 1
Time frame: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Placebo-corrected Change From Baseline for PR Interval on Day 8
Time frame: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Time frame: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Time frame: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Change From Baseline in QTcF Evaluated at Drug-specific Tmax for Padsevonil
Time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Change From Baseline in QTcF Evaluated at Drug-specific Tmax for Metabolite 1
Time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Change From Baseline in QTcF Evaluated at Drug-Specific Tmax for Metabolite 2
Time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Maximum Observed Plasma Concentration at Steady State (Cmax, ss) for Padsevonil
Time frame: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Time of Observed Maximum Concentration (Tmax) at Steady State for Padsevonil
Time frame: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Area Under the Plasma Concentration Time Curve (AUCtau) at Steady State for Padsevonil
Time frame: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdose
Percentage of Participants With Adverse Events From Baseline to Safety Follow-up (up to Day 67)
Time frame: From Baseline to Safety Follow-up (up to Day 67)
Percentage of Participants With Serious Adverse Events From Baseline to Safety Follow-up (up to Day 67)
Time frame: From Baseline to Safety Follow-up (up to Day 67)
Percentage of Participants With Treatment Related Adverse Events From Baseline to Safety Follow-up (up to Day 67)
Time frame: From Baseline to Safety Follow-up (up to Day 67)
Percentage of Participants With Adverse Events Leading to Discontinuation of the Study From Baseline to Safety Follow-up (up to Day 67)
Time frame: From Baseline to Safety Follow-up (up to Day 67)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Padsevonil and Moxifloxacin in people with Healthy Study Participants, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil (time frame: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose). 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 18 Jun 2021.