Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT04964258
Eligibility Criteria:
Inclusion Criteria:
For All Cohorts
1. Must have a body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2).
2. Continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to screening and through discharge.
3. Be judged to be in good health (example, no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug or invasive procedure.
For Japanese participants in Part 5 (Cohorts 28 to 32 only):
4. Has 2 Japanese parents and 4 Japanese grandparents, as confirmed by interview.
Exclusion Criteria:
1. Participated in another investigational study within 4 weeks (or based on local regulations) or within 5 half-lives of the investigational product before the screening visit. The 4-week or 5 half-lives window will be derived from the date of the last dose and/or adverse event (AE) related to the study procedure in the previous study to the screening visit of the current study.
2. Has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
3. Has a known hypersensitivity or contraindication to any component of TAK 105.
4. Has positive pregnancy test or is lactating or breastfeeding.
5. Has known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.
6. Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until the last follow-up visit.
7. With history or presence of:
* 3 or more incidences of syncope (example, vasovagal) within the last 5 years prior to screening;
* A family history of unexplained sudden death or channelopathy;
* Brugada syndrome (RBBB \[right bundle branch block\] pattern with ST-elevation in leads V1 V3);
* CV or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion, symptomatic or significant cardiac arrhythmia, supraventricular or ventricular tachycardia, second-degree atrioventricular (AV) block type 2, third degree AV block, prolonged QT interval with Fridericia correction method (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities;
* Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
* Any clinically significant ECG findings or medical history including: long or short QTcF (over 450 milli second \[msec\] or less than 360 msec), bifascicular block or QRS greater than equal to (\>=)120 msec or PR interval \> 200 msec at screening or Day 1 pre-Hour 0;
* Has a documented history of sinus bradycardia less than (\<) 45 beats per minute \[bpm\]) based upon vital signs assessments, sinoatrial block as evidenced on ECG or sinus pause \>=3 seconds on ECG or predose telemetry.
8. Has an average semi recumbent blood pressure (BP) less than 90 (systolic) and 60 (diastolic) millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive.
9. From screening to Day -2, participants with an average semirecumbent heart rate (HR) \<55 or \>100 beats per minute (bpm) should be excluded. From Day -2 to predose, enrollment of participants with an average HR \<55 or \>100 bpm will be left to the judgment of the investigator, unless HR is \<50 bpm, which must be discussed with the medical monitor for approval.
10. Has orthostatic hypotension defined as a decrease in systolic BP (SBP) \>=20 mmHg or a decrease in diastolic BP (DPB) \>=10 mmHg at approximately 2 minutes of standing when compared with BP from the semirecumbent position at screening to predose assessments, inclusive.
11. Has postural orthostatic tachycardia, defined as an increase of \>30 bpm or HR \>120 bpm at approximately 2 minutes of standing, at screening to predose assessments, inclusive.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04964258
Study Brief:
Protocol Section:
NCT04964258