ADHDPhase 1NCT01924143
TD-9855 Mass Balance Study
A Phase 1 study testing TD-9855 in people with ADHD and Fibromyalgia, run by Theravance Biopharma at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Fibromyalgia
- What is being tested?
- TD-9855
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone [FSH] >40 IU/mL)
- Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg
- Negative for hepatitis B, hepatitis C, and HIV antibody
Who cannot join
- Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts
- 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])
- Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -1. Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-9855 Following a Single Oral Dose Containing Approximately 100 µCi [14C]-Labeled TD-9855 (20 mg) in Healthy Subjects
The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855
- Conditions
- ADHD, Fibromyalgia
- Being tested
- TD-9855
- Keywords
- ADHD, Fibromyalgia
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-9855Drug
radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)
| Study group | Role | What they receive |
|---|---|---|
| TD-9855 | Experimental | Not described Receives: Drug: TD-9855 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.
Measured: 1-21 Days
Secondary outcomes (9)
Pharmacokinetics of total drug-related material and TD-9855: Cmax
Whole blood and plasma concentrations
Measured: 1-21 Days
PK: Tmax
Whole blood and plasma concentrations
Measured: 1-21 Days
PK: AUCt
Whole blood and plasma concentrations
Measured: 1-21 Days
PK: AUCinf
Measured: 1-21 Days
PK: CL/F (Renal clearance)
Urine
Measured: 1-21 Days
PK: Vz/F (oral volume of distribution during the terminal phase)
Measured: 1-21 Days
PK: amount excreted in urine (Ae)
Urine
Measured: 1-21 Days
PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)
Urine
Measured: 8-21 Days
Metabolic profiles in plasma and excreta
Measured: 1-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924143
- Sponsor's protocol ID
- 0105
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2013
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-9855 Following a Single Oral Dose Containing Approximately 100 µCi [14C]-Labeled TD-9855 (20 mg) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01924143
- Acronym / sponsor ID
- 0105
- Conditions
- ADHD, Fibromyalgia
- Keywords
- ADHD, Fibromyalgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Aug 2013 (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 the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TD-9855 | Experimental | Drug: TD-9855 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone [FSH] >40 IU/mL)
- Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg
- Negative for hepatitis B, hepatitis C, and HIV antibody
Key exclusion criteria (4 listed)
- Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts
- 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])
- Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -1. Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.
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-9855radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg) | Drug | TD-9855 |
Primary outcome
To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
Time frame: 1-21 Days
Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.
9 secondary outcomes
Pharmacokinetics of total drug-related material and TD-9855: Cmax
Time frame: 1-21 Days
PK: Tmax
Time frame: 1-21 Days
PK: AUCt
Time frame: 1-21 Days
PK: AUCinf
Time frame: 1-21 Days
PK: CL/F (Renal clearance)
Time frame: 1-21 Days
PK: Vz/F (oral volume of distribution during the terminal phase)
Time frame: 1-21 Days
PK: amount excreted in urine (Ae)
Time frame: 1-21 Days
PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)
Time frame: 8-21 Days
Metabolic profiles in plasma and excreta
Time frame: 1-21 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 19 Jan 2021.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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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-9855 in people with ADHD and Fibromyalgia, run by Theravance Biopharma 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 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 19 Jan 2021. 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?
To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855 (time frame: 1-21 Days). 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 19 Jan 2021.