New constipation drug tested in young and elderly volunteers
NCT ID NCT01655771
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 Hide 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.
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
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