HealthyPhase 1NCT01568411
A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211
A Phase 1 study testing TD-1211 and TD-1211+ itraconazole in people with Healthy, run by Glycyx Therapeutics at 1 site in United States.
Trial summary
This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4) and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg tablet of TD- 1211 administered orally to fasted subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TD-1211 and TD-1211+ itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2012
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written, signed informed consent
- Male and female subjects 18 to 50 years of age (inclusive)
- Body mass index 19 to 30 kg/m2 (inclusive), and weigh at least 55 kg
- No clinically important abnormal physical findings at the screening or Period 1, Day -1 examinations
- Normal blood pressure (BP) and heart rate (HR). These will be measured after resting seated or supine for approximately 5 minutes. Normal BP is defined as 90 to 140 mm Hg systolic and 50 to 85 mm Hg diastolic. Normal HR is defined as 45 to 90 beats per minute
- Negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody within the last 3 months (documentation must be provided for confirmation)
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- No clinically relevant abnormalities in the results of Screening or Period 1, Day -1 laboratory evaluations
- Ability to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and direction of the clinic staff
- For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Period 1, Day -1. Female subjects should not be breast feeding. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or IUD with documented failure rate of <1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with an additional double barrier method, or sexual abstinence. Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation or are at least 2 years postmenopausal
- All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after study dosing
Who cannot join
- Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, or neurological disease
- Any condition possibly affecting drug absorption (e.g., previous surgery on the GI tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
- Any other condition that, in the opinion of the Investigator, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
- Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
- Unwilling to abstain from ingestion of caffeine or xanthine containing products (e.g., tea, coffee, chocolate, cola, etc.) beginning 48 hours before the dosing of study medication (Day 1) until the final PK sample in each period
- History of hypersensitivity to drugs with a clinically significant reaction
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- Any history of alcoholism or drug abuse (in the past year) or positive screen for drugs of abuse or alcohol at Screening or Day -1 of each period.
- Unwilling to abstain from alcohol beginning 48 hours prior to study dose administration (Day 1) until the collection of the final PK sample in each period.
- Use or have used tobacco containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) within 6 months prior to Screening
- Consumed grapefruit and/or grapefruit containing juice within 14 days, or apple or orange juice within 7 days prior to admission to the unit on Period 1, Day -1
- Unwilling to abstain from ingestion of grapefruit, orange or apple juice throughout the duration of the study including the washout period.
- Unwilling to abstain from any strenuous physical exercise (such as weight training, aerobics) 48 hours before the screening examination and 72 hours prior to study drug administration (Day 1) until collection of the final PK sample in each period
- Acute illness (GI illness, infection [e.g., influenza] or known inflammatory process) on screening and/or admission to the clinical research unit for Period 1
- Use of prescription drugs or any chronic over the counter medication including herbals within 7 days (or 14 days if the drug is a potential inducer or inhibitor of CYP3A4 or P gp [e.g., St John's Wort, rifampin, cyclosporine, or ritonavir]) or five half lives (whichever is longer) prior to Period 1, Day -1 or required continuing use during study participation, with the following exceptions:
- Routine vitamins or minerals
- Contraceptives and hormone replacement therapy (HRT)
- A daily dose of acetaminophen (up to 1000 mg) or ibuprofen (up to 400 mg) if required on study
- Have donated blood or blood components within the 8 weeks prior to Screening. The investigator should instruct subjects who participate in this study not to donate blood or blood components for 8 weeks after the completion of the study
- Have an abnormal screening ECG indicating a second or third degree AV block, or one or more of the following: QRS >110 msec, QTc F >450 msec, PR interval >240 msec. Any rhythm other than sinus rhythm, which is interpreted by the investigator to be clinically significant
- Personal or family history of congenital long QT syndrome or family history of sudden death
- Known hypersensitivity towards or intolerance of TD 1211, itraconazole, or their formulation excipients contained in TD 1211 or itraconazole
- Previous participation in another trial of TD 1211
- Subjects who, for any reason, are deemed by the investigator to be inappropriate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211
This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4) and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg tablet of TD- 1211 administered orally to fasted subjects.
- Conditions
- Healthy
- Being tested
- TD-1211, TD-1211+ itraconazole
- Keywords
- None - normal volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1211Drug
Period 1
TD-1211+ itraconazoleDrug
Period 2
| Study group | Role | What they receive |
|---|---|---|
| TD-1211 | Active comparator | Not described Receives: Drug: TD-1211 |
| TD-1211+ itraconazole | Active comparator | Not described Receives: Drug: TD-1211+ itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in pk parameters
Assess the effect of CYP3A4 and P gp inhibition with itraconazole on the PK disposition of a single oral dose of TD-1211
Endpoints included plasma PK parameters for TD-1211:
- AUC
- Cmax
- Tmax
- t1/2
- CL/F
- Vz/F
Measured: 96 hours
Secondary outcomes (1)
Number of subjects with adverse events
Assess the safety and tolerability of a single dose of TD-1211 when administered with an inhibitor of CYP3A4 and P gp
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01568411
- Sponsor's protocol ID
- 0089
- Status last verified
- Jan 2021
- First submitted
- 23 Mar 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 Phase 1, Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211
- ClinicalTrials.gov ID
- NCT01568411
- Acronym / sponsor ID
- 0089
- Conditions
- Healthy
- Keywords
- None - normal volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Glycyx TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Apr 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.
This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4) and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg tablet of TD- 1211 administered orally to fasted subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-1211 | Active comparator | Drug: TD-1211 |
| TD-1211+ itraconazole | Active comparator | Drug: TD-1211+ itraconazole |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Willing and able to give written, signed informed consent
- Male and female subjects 18 to 50 years of age (inclusive)
- Body mass index 19 to 30 kg/m2 (inclusive), and weigh at least 55 kg
- No clinically important abnormal physical findings at the screening or Period 1, Day -1 examinations
- Normal blood pressure (BP) and heart rate (HR). These will be measured after resting seated or supine for approximately 5 minutes. Normal BP is defined as 90 to 140 mm Hg systolic and 50 to 85 mm Hg diastolic. Normal HR is defined as 45 to 90 beats per minute
Key exclusion criteria (23 listed)
- Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, or neurological disease
- Any condition possibly affecting drug absorption (e.g., previous surgery on the GI tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
- Any other condition that, in the opinion of the Investigator, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
- Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
- Unwilling to abstain from ingestion of caffeine or xanthine containing products (e.g., tea, coffee, chocolate, cola, etc.) beginning 48 hours before the dosing of study medication (Day 1) until the final PK sample in each period
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-1211Period 1 | Drug | TD-1211 |
| TD-1211+ itraconazolePeriod 2 | Drug | TD-1211+ itraconazole |
Primary outcome
Differences in pk parameters
Time frame: 96 hours
Assess the effect of CYP3A4 and P gp inhibition with itraconazole on the PK disposition of a single oral dose of TD-1211 Endpoints included plasma PK parameters for TD-1211: * AUC * Cmax * Tmax * t1/2 * CL/F * Vz/F
1 secondary outcome
Number of subjects with adverse events
Time frame: 96 hours
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 and TD-1211+ itraconazole in people with Healthy, 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 10 inclusion and 23 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?
Differences in pk parameters (time frame: 96 hours). 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.