A Study of TAK-495 in Healthy Adults

A Randomized , Double-Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK-495 in Healthy Participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250132

Enrollment

126

Registered

2026-02-17

Start date

2026-02-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Interventions

Healthy adult participants will receive single and/or multiple oral doses of TAK-495.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
1.Number of Participants With At Least 1 TEAE Postdose Timeframe: 69 Days as a maximum TEAE: treatment-emergent adverse event.	—

Secondary

Measure	Time frame
1.PK of TAK-495 Following Single/Multiple Oral Doses in Healthy Adults	—

Countries

Japan, United States

Contacts

Public ContactContact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

smb.Japanclinicalstudydisclosure@takeda.com+81-6-6204-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026