A Phase 1 interventional study of Soticlestat and Placebo in Healthy Volunteers, sponsored by Takeda. Withdrawn. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Takeda · Phase 1, Interventional, and Other
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.
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.
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.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
No clinically significant history or presence of ECG findings as judged by the Investigator or designee, including each criterion as listed below:
Exclusion Criteria:
History or presence of any of the following, deemed clinically significant by the Investigator or designee:
Unable to refrain from or anticipates the use of:
Regimen 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.
Drug: Soticlestat · Drug: Placebo · Drug: Moxifloxacin
Regimen 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.
Drug: Soticlestat · Drug: Placebo · Drug: Moxifloxacin
Regimen 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.
Drug: Soticlestat · Drug: Placebo · Drug: Moxifloxacin
Regimen 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.
Drug: Soticlestat · Drug: Placebo · Drug: Moxifloxacin
Soticlestat tablet.
Also known as: TAK-935
Soticlestat placebo-matching tablet.
Moxifloxacin over-encapsulated tablet.
Moxifloxacin placebo-matching capsule.
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.
Time frame: Day -1 up to 24 hours post-dose
Change From Baseline in HR
HR will be measured by continuous ECG recordings.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
Change From Baseline in PR Interval of the ECG (PR)
PR will be measured by continuous ECG recordings.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
Change From Baseline in QRS Interval of the ECG (QRS)
QRS will be measured by continuous ECG recordings.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
Placebo-corrected Change From Baseline in HR
Placebo-corrected HR will be measured by continuous ECG recordings.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
Placebo-corrected Change From Baseline in PR Interval of ECG
Placebo-corrected PR interval will be measured by continuous ECG recordings.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
Placebo-corrected Change From Baseline in QRS Interval of ECG
Placebo-corrected QRS interval will be measured by continuous ECG recordings.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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).
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Day 1: Pre-dose up to 24 hours post-dose
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.
Time frame: Baseline (Day 1) up to 14 days after the last dose of study drug in Period 4 (Day 39)
Cmax: Maximum Observed Plasma Concentration for Soticlestat
Time frame: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Soticlestat
Time frame: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat
Time frame: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat
Time frame: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose
T1/2z: Terminal Phase Elimination Half-life for Soticlestat
Time frame: Day 1: Pre-dose and at multiple timepoints (up to 24 hours) post-dose
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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