OICPhase 1NCT01702194
TD-1211 IV/Oral Mass Balance Study
A Phase 1 study testing TD-1211 IV [C14] and TD-1211 PO [C14] in people with OIC, run by Glycyx Therapeutics at 1 site in United States.
Trial summary
The purpose of this study is to determine TD-1211 is processed by the body. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- OIC
- What is being tested?
- TD-1211 IV [C14] and TD-1211 PO [C14]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2013
- Phase
- Phase 1
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, nonsmoking male, 18 to 50 years old, inclusive.
- Agrees to use a highly effective method of birth control.
- Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
- Willing and able to give written informed consent.
Who cannot join
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- Hemoglobin <14.1 g/dL or hematocrit < 40.6% at Screening.
- History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
- Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]).
- Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects
The purpose of this study is to determine TD-1211 is processed by the body.
Read the detailed description
This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.
- Conditions
- OIC
- Being tested
- TD-1211 IV [C14], TD-1211 PO [C14]
- Keywords
- OIC, Opioid Induced Constipation, Constipation
- Medical subject headings
- Opioid-Induced Constipation, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1211 IV [C14]Drug
Also called TD-1211
TD-1211 PO [C14]Drug
Also called TD-1211
| Study group | Role | What they receive |
|---|---|---|
| TD-1211 IV [C14] | Experimental | TD-1211 IV [C14] Receives: Drug: TD-1211 IV [C14] |
| TD-1211 PO [C14] | Experimental | TD-1211 PO [C14] Receives: Drug: TD-1211 PO [C14] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Measured: 0 to 168 hours postdose
Peak plasma concentration (Cmax)
Measured: 0 to 168 hours postdose
Time to peak plasma concentration (Tmax)
Measured: 0 to 168 hours postdose
Half-life (T 1/2)
Measured: 0 to 168 hours postdose
Percent total recovery of radioactivity in blood, urine, and feces
Measured: 0 to 312 hours postdose
Secondary outcomes (1)
Number of participants with adverse events
Measured: Baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OICStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycyx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702194
- Sponsor's protocol ID
- 0087
- Status last verified
- May 2026
- First submitted
- 2 Oct 2012
- 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 Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01702194
- Acronym / sponsor ID
- 0087
- Conditions
- OIC
- Keywords
- OIC, Opioid Induced Constipation, Constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glycyx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Oct 2012 (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 determine TD-1211 is processed by the body.
Detailed description
This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-1211 IV [C14] | Experimental | Drug: TD-1211 IV [C14]TD-1211 IV [C14] |
| TD-1211 PO [C14] | Experimental | Drug: TD-1211 PO [C14]TD-1211 PO [C14] |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, nonsmoking male, 18 to 50 years old, inclusive.
- Agrees to use a highly effective method of birth control.
- Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
- Willing and able to give written informed consent.
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- Hemoglobin <14.1 g/dL or hematocrit < 40.6% at Screening.
- History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
- Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]).
- Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
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-1211 IV [C14]Also: TD-1211 | Drug | TD-1211 IV [C14] |
| TD-1211 PO [C14]Also: TD-1211 | Drug | TD-1211 PO [C14] |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 0 to 168 hours postdose
Peak plasma concentration (Cmax)
Time frame: 0 to 168 hours postdose
Time to peak plasma concentration (Tmax)
Time frame: 0 to 168 hours postdose
Half-life (T 1/2)
Time frame: 0 to 168 hours postdose
Percent total recovery of radioactivity in blood, urine, and feces
Time frame: 0 to 312 hours postdose
1 secondary outcome
Number of participants with adverse events
Time frame: Baseline to 14 days
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TD-1211 IV [C14] and TD-1211 PO [C14] in people with OIC, run by Glycyx Therapeutics at 1 site 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 4 inclusion and 5 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Area under the plasma concentration versus time curve (AUC) (time frame: 0 to 168 hours postdose). The study lists 5 primary outcomes in all. 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; AzTrials last refreshed its copy on 26 Oct 2026.