TAK-935-1001

Terminated / Withdrawn

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

Clinicaltrials.gov

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.

Interventional Phase 1 clinical trial.

What medical conditions were being studied?

Healthy Volunteers

What was the clinical trial testing?

Placebo, Soticlestat, Moxifloxacin

How many participants were enrolled?

Were placebos part of the clinical trial?

Yes

When was the clinical trial conducted?

Oct 2022 - Dec 2022

How long was participation in the clinical trial?

Participants will be in the study for about 63 days.

Sex

All

Age

18-55 years

Healthy volunteers?

Yes

Both men and women can take part.

Must be an adult from18 to 55 years old.

Must be considered healthy by the study doctor. In this study, healthy means no symptoms of any active or chronic disease or condition.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Placebo-corrected Change From Baseline in Corrected QT Interval (QTc) [Time Frame: Day -1 up to 24 hours post-dose]

Secondary outcome measures

Change From Baseline in HR [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Change From Baseline in QTc With the Methods Not Selected as Primary [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Change From Baseline in Individualized HR-corrected QT interval (QTcS) [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Change From Baseline in Optimized QT Interval (QTcI) [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Change From Baseline in PR Interval of the ECG (PR) [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Change From Baseline in QRS Interval of the ECG (QRS) [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Placebo-corrected Change From Baseline in HR [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 [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Placebo-corrected Change From Baseline in PR Interval of ECG [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Placebo-corrected Change From Baseline in QRS Interval of ECG [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Number of Participants with Categorical Outlier Values for HR [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Number of Participants with Categorical Outliers Values for PR [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Number of Participants with Categorical Outliers Values for QRS [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Number of Participants with Categorical Outliers Values for QTc [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Percentage of Participants with Change From Baseline in ECG Morphology [Time Frame: Day 1: Pre-dose up to 24 hours post-dose]

Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) [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]

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

About this clinical trial

At a glance