NIPH Clinical Trials Search

A Study of TAK-495 in Healthy Adults

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Healthy Participants
Date of first enrollment	17/02/2026
Target sample size	126
Countries of recruitment	United States,Japan
Study type	Interventional
Intervention(s)	Healthy adult participants will receive single and/or multiple oral doses of TAK-495.

Outcome(s)

Primary Outcome	1.Number of Participants With At Least 1 TEAE Postdose Timeframe: 69 Days as a maximum TEAE: treatment-emergent adverse event.
Secondary Outcome	1.PK of TAK-495 Following Single/Multiple Oral Doses in Healthy Adults

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. The participant must have no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic) at screening and at Day -1. 2. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products for at least 3 months before the first dose of trial intervention or first trial assessment.
Exclude criteria	1. The participant has a history of cancer in past 10 years 2. The participant has a history of significant multiple and/or severe allergies, has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food, or has a known hypersensitivity to any component of the formulation of TAK-495 or related compounds.