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Healthy VolunteersPhase 1NCT05309902

A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval

A Phase 1 study testing Soticlestat and Moxifloxacin in people with Healthy Volunteers, run by Takeda.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main aim is to see if soticlestat has any effect in the heart rate. Participants will receive 4 doses of soticlestat in tablets and will complete some assessment which include to record activity of the heart and collection of blood samples. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Soticlestat and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
11 Oct 2022to 6 Dec 2022
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

  • Male participants agree to comply with any applicable contraceptive requirements of the protocol.
  • Body mass index (BMI) greater than or equal to (>=)18.0 and <=32.0 kilogram per square meter (kg/m^2) at screening.
  • Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing, based on participant self-reporting.
  • No clinically significant history or presence of ECG findings as judged by the Investigator or designee, including each criterion as listed below:
  • Normal sinus rhythm (HR between 45 bpm and 100 bpm inclusive) at screening and check-in;
  • QTcF is <=450 ms (males) or <=470 ms (females) at screening and check-in;
  • QRS interval <=110 ms; if >110 ms, result will be confirmed by a manual over read at screening and check-in;
  • PR interval <=220 ms at screening and check-in.

Who cannot join

  • Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of any of the following, deemed clinically significant by the Investigator or designee:
  • epilepsy, seizure, or convulsion, tremor or related symptoms;
  • risk factors for Torsade de Pointes (TdP) (example, heart failure, unexplained syncope, cardiomyopathy, or family history of Long QT Syndrome);
  • family history of sudden death;
  • sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;
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  • ischemic heart disease, poorly controlled hypertension, or other cardiovascular disorder;
  • T wave flattening or other abnormalities which in the opinion of the investigator or designee may interfere with the analysis of QT intervals;
  • clinically significant hyper- or hypokalemia.
  • Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the clinical judgement of the Investigator has a risk of suicide or has made a suicide attempt in the previous 12 months prior to the first dosing.
  • Positive urine drug or alcohol results at screening or at check-in.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or antibody test for hepatitis C virus (HCV).
  • Unable to refrain from or anticipates the use of:
  • Any vaccines, drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first dosing.
  • Any drugs known to be significant inducers of cytochrome P450 (CYP)3A, CYP2C19, uridine 5' diphospho-glucuronosyltransferase (UGT)1A9 or (UGT)2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of Pharmacokinetics (PK)/pharmacodynamics interaction with study drug.
  • Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day.

About this study

Official title: A Phase 1, Double-Blinded, Placebo- and Active-Controlled, Randomized Study to Investigate the Potential of Soticlestat to Prolong the QTc Interval in Healthy Adult Participants

The main aim is to see if soticlestat has any effect in the heart rate.

Participants will receive 4 doses of soticlestat in tablets and will complete some assessment which include to record activity of the heart and collection of blood samples.

Then, the clinic will contact the participants 14 days after their final dose of soticlestat to check if they have any health problems.

Read the detailed description

The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants for the purpose of this study. This study will assess the effect of single-dose of soticlestat on the heart rate (QTc prolongation). The study will enroll approximately 60 participants.

Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatments sequences.

  • Sequence 1: (Regimen A+ Regimen B + Regimen C + Regimen D)
  • Sequence 2: (Regimen B+ Regimen D + Regimen A + Regimen C)
  • Sequence 3: (Regimen C+ Regimen A + Regimen D + Regimen B)
  • Sequence 4: (Regimen D+ Regimen C + Regimen B + Regimen A)

All participants will receive all 4 treatment regimens. Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This is a single-center trial. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 63 days including screening period and follow-up period.

Being tested
Soticlestat, Placebo, Moxifloxacin
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SoticlestatDrug

    Also called TAK-935

    Soticlestat tablet.

  • PlaceboDrug

    Soticlestat placebo-matching tablet.

  • MoxifloxacinDrug

    Moxifloxacin over-encapsulated tablet.

  • PlaceboDrug

    Moxifloxacin placebo-matching capsule.

Study groups in NCT05309902
Study groupRoleWhat they receive
Sequence 1: (Regimen A + Regimen B + Regimen C + Regimen D)ExperimentalRegimen A (soticlestat 300 milligram [mg] tablets + soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 1, followed by at least 7 days washout period, followed by Regimen B (soticlestat 900 mg tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 2, followed by at least 7 days washout period, followed by Regimen C (soticlestat placebo-matching tablets + moxifloxacin 400 mg over-encapsulated tablet), orally, in fasting condition, once on Day 1 of Treatment Period 3, followed by at least 7 days washout period, followed by Regimen D (soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 4.
Receives: Drug: Soticlestat; Drug: Placebo; Drug: Moxifloxacin
Sequence 2: (Regimen B + Regimen D + Regimen A + Regimen C)ExperimentalRegimen B (soticlestat 900 mg tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 1, followed by at least 7 days washout period, followed by Regimen D (soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 2, followed by at least 7 days washout period, followed by Regimen A (soticlestat 300 mg tablets + soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition, once on Day 1 of Treatment Period 3, followed by at least 7 days washout period, followed by Regimen C (soticlestat -matching tablets + moxifloxacin 400 mg over-encapsulated tablet), orally, in fasting condition once on Day 1 of Treatment Period 4.
Receives: Drug: Soticlestat; Drug: Placebo; Drug: Moxifloxacin
Sequence 3: (Regimen C + Regimen A + Regimen D + Regimen B)ExperimentalRegimen C (soticlestat placebo-matching tablets + moxifloxacin 400 mg over-encapsulated tablet), orally, in fasting condition once on Day 1 of Treatment Period 1, followed by at least 7 days washout period, followed by Regimen A (soticlestat 300 mg tablets + soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 2, followed by at least 7 days washout period, followed by Regimen D (soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition, once on Day 1 of Treatment Period 3, followed by at least 7 days washout period, followed by Regimen B (soticlestat 900 mg tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 4.
Receives: Drug: Soticlestat; Drug: Placebo; Drug: Moxifloxacin
Sequence 4: (Regimen D + Regimen C + Regimen B + Regimen A)ExperimentalRegimen D (soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 1, followed by at least 7 days washout period, followed by Regimen C (soticlestat placebo-matching tablets + moxifloxacin 400 mg over-encapsulated tablet), orally, in fasting condition once on Day 1 of Treatment Period 2, followed by at least 7 days washout period, followed by Regimen B (soticlestat 900 mg tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition, once on Day 1 of Treatment Period 3, followed by at least 7 days washout period, followed by Regimen A (soticlestat 300 mg tablets + soticlestat placebo-matching tablets + moxifloxacin placebo-matching capsule), orally, in fasting condition once on Day 1 of Treatment Period 4.
Receives: Drug: Soticlestat; Drug: Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placebo-corrected Change From Baseline in Corrected QT Interval (QTc)

    The QTc interval will be measured by continuous electrocardiogram (ECG) recordings. The primary QT correction method will be Fridericia's correction. In case a substantial HR effect is observed on-treatment with soticlestat, drug-free QT/RR data will be collected over a range of Heart Rate (HR) seen off-treatment to allow the generation of individualized QT correction methods. QTc will be calculated from Day -1 of the first treatment period both during the periods of supine rest (QTcS) and from all evaluable QT/RR pairs in the 24-hour recording (QTcI). The method that removes the HR dependence of the QT interval most efficiently will be chosen as primary correction method. The analysis for QTc will be based on a linear mixed-effects model with ΔQTc as the dependent variable, period, sequence, time (that is, nominal post-dose time point), treatment, and time-by-treatment interaction as fixed effects, and baseline QTc as a covariate.

    Measured: Day -1 up to 24 hours post-dose

Secondary outcomes (21)

  1. Change From Baseline in HR

    HR will be measured by continuous ECG recordings.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  2. Change From Baseline in QTc With the Methods Not Selected as Primary

    The QTc interval will be measured by continuous ECG recordings. Pre-dose will be the average of the derived ECG intervals from the 3 ECG time-points (-0.75, -0.5, and -0.25 hours) prior to treatment administration on Day 1 within each respective period.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  3. Change From Baseline in Individualized HR-corrected QT interval (QTcS)

    The QTcS interval will be measured by continuous ECG recordings and QT/RR interval of ECG (RR) data obtained at supine resting time points. The analysis for QTcS will be based on a linear mixed-effects model.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  4. Change From Baseline in Optimized QT Interval (QTcI)

    The QTcI interval will be measured by continuous ECG recordings and QT/RR data obtained at supine resting time points. The analysis for QTcI will be based on a linear regression model.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  5. Change From Baseline in PR Interval of the ECG (PR)

    PR will be measured by continuous ECG recordings.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  6. Change From Baseline in QRS Interval of the ECG (QRS)

    QRS will be measured by continuous ECG recordings.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  7. Placebo-corrected Change From Baseline in HR

    Placebo-corrected HR will be measured by continuous ECG recordings.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  8. Placebo-corrected Change From Baseline in QTc With the Methods Not Selected as Primary

    Placebo-corrected QTc interval will be measured by continuous ECG recordings. Pre-dose will be the average of the derived ECG intervals from the 3 ECG time-points (-0.75, -0.5, and -0.25 hours) prior to treatment administration on Day 1 within each respective period.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  9. Placebo-corrected Change From Baseline in PR Interval of ECG

    Placebo-corrected PR interval will be measured by continuous ECG recordings.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  10. Placebo-corrected Change From Baseline in QRS Interval of ECG

    Placebo-corrected QRS interval will be measured by continuous ECG recordings.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  11. Number of Participants with Categorical Outlier Values for HR

    Number of participants with categorical outlier values for HR will be determined. A participant will be determined as an outlier if the following criteria were met for the ECG intervals at any time point: Decrease of HR from baseline greater than (>) 25 percent (%) resulting in HR less than (<) 50 beats per minute (bpm) and increase in HR from baseline resulting in HR >100 bpm.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  12. Number of Participants with Categorical Outliers Values for PR

    Number of participants with categorical outlier values for PR will be determined. A participant will be determined as an outlier if the following criteria were met for the ECG interval at any time point: Increase of PR from Baseline >25% resulting in PR >200 millisecond (ms).

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  13. Number of Participants with Categorical Outliers Values for QRS

    Number of participants with categorical outliers values for QRS will be determined. A participant will be determined as an outlier if the following criteria were met for the ECG interval at any time point: Increase of QRS from Baseline >25% resulting in QRS >120 ms.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  14. Number of Participants with Categorical Outliers Values for QTc

    Number of participants with categorical outliers values for QTc will be determined. A participant will be determined as an outlier if the following criteria were met for the ECG interval at any time point: Increase in treatment-emergent value >450 and less than or equal to (<=) 480 ms; >480 and <=500; change from Baseline of >30 and <=60 ms or >60 ms.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  15. Percentage of Participants with Change From Baseline in ECG Morphology

    ECG morphological analyses will be performed using the ECG waveform interpretation as defined by the central ECG laboratory's cardiologist.

    Measured: Day 1: Pre-dose up to 24 hours post-dose

  16. Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: Baseline (Day 1) up to 14 days after the last dose of study drug in Period 4 (Day 39)

  17. Cmax: Maximum Observed Plasma Concentration for Soticlestat

    Measured: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose

  18. AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Soticlestat

    Measured: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose

  19. AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat

    Measured: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose

  20. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat

    Measured: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose

  21. T1/2z: Terminal Phase Elimination Half-life for Soticlestat

    Measured: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2022
  2. Study start11 Oct 2022 (estimated)
  3. Primary completion6 Dec 2022 (estimated)
  4. Study completion6 Dec 2022 (estimated)

Why it stopped: Study not needed

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05309902
Sponsor's protocol ID
TAK-935-1001
Status last verified
Aug 2026
First submitted
30 Mar 2022
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Soticlestat and Moxifloxacin in people with Healthy Volunteers, run by Takeda.

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 16 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 19 Aug 2026. 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?

Placebo-corrected Change From Baseline in Corrected QT Interval (QTc) (time frame: Day -1 up to 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05309902.

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 19 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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