HealthyPhase 1/2NCT01040637
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
A Phase 1/2 study testing TD-1211 in people with Healthy and Opioid-induced Constipation, run by Glycyx Therapeutics at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Opioid-induced Constipation
- What is being tested?
- TD-1211
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Oct 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 65 years of age, inclusive
- Healthy subjects and subjects with documented OIC on stable opioid regimen
- Willingness to stop all laxatives throughout the OIC screening and treatment period
Who cannot join
- Any clinically significant finding in healthy subjects
- Have participated in another clinical trial of an investigational drug 30 days prior to screening
- History of chronic constipation prior to opioid therapy in OIC subjects
- Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Research Unit
Pasadena, California, 91105
Clinical Research Unit
Salt Lake City, Utah, 84106
Clinical Research Unit
San Antonio, Texas, 78209
About this study
Official title: A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
- Conditions
- Healthy, Opioid-induced Constipation
- Being tested
- TD-1211, Placebo
- Keywords
- Healthy subjects
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1211Drug
Dose level 1
TD-1211Drug
Dose level 2
TD-1211Drug
Dose level 3
TD-1211Drug
Dose Level 4
TD-1211Drug
Ascending doses
TD-1211Drug
Ascending doses
TD-1211Drug
Ascending doses
TD-1211Drug
Ascending doses
TD-1211Drug
Ascending doses
PlaceboDrug
Ascending doses
| Study group | Role | What they receive |
|---|---|---|
| TD-1211 dose level 1 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 dose level 2 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 dose level 3 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 dose level 4 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 OIC dose level 1 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 OIC dose level 2 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 OIC dose level 3 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 OIC dose level 4 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| TD-1211 OIC dose level 5 | Experimental | Ascending doses Receives: Drug: TD-1211 |
| Placebo | Placebo comparator | Ascending doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation
Measured: Daily pre and post dose assessments throughout the duration of the study period
Secondary outcomes (1)
Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration
Measured: Daily pre and post dose assessments throughout the duration of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycyx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040637
- Sponsor's protocol ID
- 0067
- Status last verified
- May 2026
- First submitted
- 22 Dec 2009
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT01040637
- Acronym / sponsor ID
- 0067
- Conditions
- Healthy, Opioid-induced Constipation
- Keywords
- Healthy subjects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Glycyx TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| TD-1211 dose level 1 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 dose level 2 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 dose level 3 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 dose level 4 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 OIC dose level 1 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 OIC dose level 2 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 OIC dose level 3 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 OIC dose level 4 | Experimental | Drug: TD-1211Ascending doses |
| TD-1211 OIC dose level 5 | Experimental | Drug: TD-1211Ascending doses |
| Placebo | Placebo comparator | Drug: PlaceboAscending doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females between 18 and 65 years of age, inclusive
- Healthy subjects and subjects with documented OIC on stable opioid regimen
- Willingness to stop all laxatives throughout the OIC screening and treatment period
Key exclusion criteria (4 listed)
- Any clinically significant finding in healthy subjects
- Have participated in another clinical trial of an investigational drug 30 days prior to screening
- History of chronic constipation prior to opioid therapy in OIC subjects
- Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-1211Dose level 1 | Drug | TD-1211 dose level 1 |
| TD-1211Dose level 2 | Drug | TD-1211 dose level 2 |
| TD-1211Dose level 3 | Drug | TD-1211 dose level 3 |
| TD-1211Dose Level 4 | Drug | TD-1211 dose level 4 |
| TD-1211Ascending doses | Drug | TD-1211 OIC dose level 1 |
| TD-1211Ascending doses | Drug | TD-1211 OIC dose level 2 |
| TD-1211Ascending doses | Drug | TD-1211 OIC dose level 3 |
| TD-1211Ascending doses | Drug | TD-1211 OIC dose level 4 |
| TD-1211Ascending doses | Drug | TD-1211 OIC dose level 5 |
| PlaceboAscending doses | Drug | Placebo |
Primary outcome
Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation
Time frame: Daily pre and post dose assessments throughout the duration of the study period
1 secondary outcome
Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration
Time frame: Daily pre and post dose assessments throughout the duration of the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TD-1211 in people with Healthy and Opioid-induced Constipation, run by Glycyx Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation (time frame: Daily pre and post dose assessments throughout the duration of the study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.