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First human test of TAK-935: can this experimental drug pass the safety check?

NCT ID NCT02201056

Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called TAK-935 in 48 healthy adults aged 19 to 55. Each participant receives a single oral dose of TAK-935 or a placebo, with doses increasing across groups. The study measures side effects, changes in lab tests, vital signs, and heart rhythm, and tracks how the body absorbs and clears the drug. The goal is to learn whether single doses are safe and well tolerated before larger studies in patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-935, an experimental drug given as an oral solution
What this could lead to
If TAK-935 proves safe and well tolerated, researchers could move it into larger studies testing whether it helps people with the condition it targets.
What could go wrong
This is a first-in-human, 48-person study of single doses in healthy volunteers, so it cannot show whether the drug works for any disease. Many experimental drugs fail later for lack of benefit or unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Start date

Jul 2014

Finished

Jul 2015

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent. 2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive at the Screening Visit. Exclusion Criteria: 1. Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality. 2. Has a known hypersensitivity to any component of the formulation of TAK-935. 3. There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Study site

    Lincoln, Nebraska, United States

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