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Healthy volunteer study sheds light on potential liver disease drug metabolism

NCT ID NCT03159390

Knowledge-focused Sponsor: Texas A&M University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study in 20 healthy adults aged 40-70 examined how the body breaks down ornithine phenylacetate, a compound being explored for liver disease. Researchers used special tracers and collected blood, urine, and muscle samples to track its metabolism. The goal was to understand how the drug is processed, not to test any treatment effect.

What this could mean

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

Active substance
ornithine phenylacetate
What this could lead to
If this study clarifies how ornithine phenylacetate is metabolized, it could help design future treatments for liver disease.
What could go wrong
This was a small, early-stage study in healthy volunteers, not patients. The results may not apply to people with liver disease, and no therapeutic benefit was tested.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Feb 2015

Finished

Apr 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 70 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 healthy subjects: * Healthy male \& female according to the investigator's or appointed staff's judgment * Age 40-70 years (to be comparable with patients with liver cirrhosis: average 54.1 +/- 9.4 years) Exclusion Criteria * Metabolic diseases including diabetes and hepatic or renal disorders * Presence of acute illness or metabolically unstable chronic illness * Failure to give informed consent * (Possible) pregnancy * Any other condition according to the PI or nurse that would interfere with the study or safety of the patient or influence the results * Unwilling to stop taking nutritional protein supplements within 5 days before test day * History of hypo- or hyper-coagulation disorders, including use of a Coumadin derivative, history of deep venous thrombosis (DVT), or pulmonary embolism (PE) at any point in lifetime * Currently taking anti-thrombotics (i.e. medical indication) and cannot stop for 3-7 days prior to test days * Allergy to local anesthetic

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As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • Texas A&M University-CTRAL

    College Station, Texas, 77843-4253, United States

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