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New constipation drug tested in young and elderly volunteers

NCT ID NCT01655771

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a single dose of TD-1211, an experimental drug for constipation, in 47 healthy adults split into younger (18-45) and older (65-85) groups. Researchers measured how the body absorbs and eliminates the drug and checked for side effects. The goal was to see if age affects drug safety and processing, not to test if it works for constipation.

What this could mean

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

Active substance
TD-1211
What this could lead to
If successful, this study could help determine safe dosing of TD-1211 for constipation in different age groups.
What could go wrong
This is an early Phase 1 trial in healthy volunteers, not patients. It only measures safety and drug levels, not whether the drug works for constipation.

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

47 people

The number who actually took part.

Start date

Aug 2012

Finished

Mar 2013

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

18 to 85 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: * For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive. * Body mass index (BMI) should be 18 to 36 kg/m2, inclusive. * At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supine systolic and diastolic blood pressure of 90 to 150 mm Hg and 50 to 90 mm Hg, respectively (2 of 3 measurements) * Subjects with mild, chronic, stable disease (e.g., controlled hypertension, non-insulin-dependent diabetes, arthritis) may be enrolled if deemed medically acceptable by the investigator * Negative for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus antibody within the last 3 months * No clinically relevant abnormalities in laboratory evaluations Exclusion Criteria: * History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if condition is well controlled and not anticipated to interfere with the objectives of the study. * Any clinically significant abnormal ECG (electrocardiogram). * Participation in another clinical trial of an investigational drug or medical device within 60 days. * Donation of ≥500 mL blood, or equivalent, within 8 weeks prior to admission day. * Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety, tolerability, or PK of the investigational drug or prevent compliance with the study protocol.

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Conditions

The condition(s) this trial relates to.

constipation disorder Opioid-Induced Constipation

As listed by the trial registrant

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

Contacts and locations

Locations

  • ICON Development Solutions

    San Antonio, Texas, 78209, United States

More trials for these conditions

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