CompletedPhase 1

TD-1211 IV/Oral Mass Balance Study

United States10 participantsStarted 2012-11

Plain-language summary

The purpose of this study is to determine TD-1211 is processed by the body.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the plasma concentration versus time curve (AUC)

Timeframe: 0 to 168 hours postdose

Peak plasma concentration (Cmax)

Timeframe: 0 to 168 hours postdose

Time to peak plasma concentration (Tmax)

Timeframe: 0 to 168 hours postdose

Half-life (T 1/2)

Timeframe: 0 to 168 hours postdose

Percent total recovery of radioactivity in blood, urine, and feces

Timeframe: 0 to 312 hours postdose

Trial details

NCT IDNCT01702194

SponsorGlycyx Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02

View on ClinicalTrials.gov More OIC trials

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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).

What they're measuring

Area under the plasma concentration versus time curve (AUC)

Timeframe: 0 to 168 hours postdose

Peak plasma concentration (Cmax)

Timeframe: 0 to 168 hours postdose

Time to peak plasma concentration (Tmax)

Timeframe: 0 to 168 hours postdose

Half-life (T 1/2)

Timeframe: 0 to 168 hours postdose

Percent total recovery of radioactivity in blood, urine, and feces

Timeframe: 0 to 312 hours postdose