Gastrointestinal Motility DisorderPhase 1NCT01644240
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
A Phase 1 study testing TD-8954 in people with Gastrointestinal Motility Disorder, run by Theravance Biopharma at 1 site in United States.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility Disorder
- What is being tested?
- TD-8954
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2 and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult males and females 18 to 45 or 65 to 85 years of age, inclusive.
- Body mass index (BMI)between 18 to 36 kg/m2, inclusive.
- Average frequency of ≥ 3 bowel movements per week.
Who cannot join
- Persistent symptoms of functional GI disorder (such as irritable bowel syndrome, functional constipation, functional dyspepsia, or other symptom-based GI disorders unexplained by a pathologically based disorder) during the 6 months prior to screening, including a history of major surgery of the GI tract, excluding cholecystectomy and appendectomy.
- History or presence of clinically significant respiratory, GI, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if the condition is well controlled and not anticipated to interfere with the objectives of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Intravenous Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.
- Conditions
- Gastrointestinal Motility Disorder
- Being tested
- TD-8954, Placebo - saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-8954Drug
Intravenous infusion
Placebo - salineDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| TD-8954 Dose 1 | Experimental | Not described Receives: Drug: TD-8954 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo - saline |
| TD-8954 Dose 2 | Experimental | Not described Receives: Drug: TD-8954 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration in plasma following dosing on Day 1
Measured: Day 1
Tmax
Time to maximum plasma concentration
Measured: Day 1
t½
Time to 50% plasma concentration
Measured: Day 1
AUC0-24
Area under the plasma concentration time curve through 24 hours after dosing.
Measured: Day 1
AUC0-∞
Area under the concentration time curve from time 0 to infinity.
Measured: Day 1
AUCtau
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
Measured: Day 1
Plasma Vz
Volume of distribution
Measured: Day 1
Plasma CL
Plasma clearance
Measured: Day 1
Cmax
Maximum plasma concentration
Measured: Day 5
Tmax
Time to reach maximum plasma concentration.
Measured: Day 5
t½
Time to 50% plasma concentration
Measured: Day 5
AUC0-24
Area under the plasma concentration time curve 24 hours following the last dose.
Measured: Day 5
AUC0-∞
Area under the plasma concentration time curve from 0 to infinity.
Measured: Day 5
AUCtau
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
Measured: Day 5
Vss
Apparent volume of distribution at steady state
Measured: Day 5
CLss
Apparent clearance
Measured: Day 5
Secondary outcomes (1)
Number of Subjects With Adverse Events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionDec 2012
Why it stopped: For business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal Motility DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Haumann, SVP, Clinical Development, Study director, Theravance Biopharma, US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644240
- Sponsor's protocol ID
- 0095
- Status last verified
- Apr 2017
- First submitted
- 13 Jul 2012
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Intravenous Dose Study to Examine the Safety, Tolerability, and Pharmacokinetics of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01644240
- Acronym / sponsor ID
- 0095
- Conditions
- Gastrointestinal Motility Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For business reasons
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD-8954 Dose 1 | Experimental | Drug: TD-8954 |
| Placebo | Placebo comparator | Drug: Placebo - saline |
| TD-8954 Dose 2 | Experimental | Drug: TD-8954 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For Cohorts 1: adult males and females age 18 to 45 years, inclusive; for Cohorts 2 and 3, adult males and females 65 to 85 years of age, inclusive; for Cohort 4, adult males and females 18 to 45 or 65 to 85 years of age, inclusive.
- Body mass index (BMI)between 18 to 36 kg/m2, inclusive.
- Average frequency of ≥ 3 bowel movements per week.
Key exclusion criteria (2 listed)
- Persistent symptoms of functional GI disorder (such as irritable bowel syndrome, functional constipation, functional dyspepsia, or other symptom-based GI disorders unexplained by a pathologically based disorder) during the 6 months prior to screening, including a history of major surgery of the GI tract, excluding cholecystectomy and appendectomy.
- History or presence of clinically significant respiratory, GI, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if the condition is well controlled and not anticipated to interfere with the objectives of the study.
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-8954Intravenous infusion | Drug | TD-8954 Dose 1, TD-8954 Dose 2 |
| Placebo - salineIntravenous infusion | Drug | Placebo |
Primary outcome
Cmax
Time frame: Day 1
Maximum concentration in plasma following dosing on Day 1
Tmax
Time frame: Day 1
Time to maximum plasma concentration
t½
Time frame: Day 1
Time to 50% plasma concentration
AUC0-24
Time frame: Day 1
Area under the plasma concentration time curve through 24 hours after dosing.
AUC0-∞
Time frame: Day 1
Area under the concentration time curve from time 0 to infinity.
AUCtau
Time frame: Day 1
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
Plasma Vz
Time frame: Day 1
Volume of distribution
Plasma CL
Time frame: Day 1
Plasma clearance
Cmax
Time frame: Day 5
Maximum plasma concentration
Tmax
Time frame: Day 5
Time to reach maximum plasma concentration.
t½
Time frame: Day 5
Time to 50% plasma concentration
AUC0-24
Time frame: Day 5
Area under the plasma concentration time curve 24 hours following the last dose.
AUC0-∞
Time frame: Day 5
Area under the plasma concentration time curve from 0 to infinity.
AUCtau
Time frame: Day 5
Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.
Vss
Time frame: Day 5
Apparent volume of distribution at steady state
CLss
Time frame: Day 5
Apparent clearance
1 secondary outcome
Number of Subjects With Adverse Events
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Brett Haumann, SVP, Clinical Development study director
Theravance Biopharma, US, Inc.
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-8954 in people with Gastrointestinal Motility Disorder, 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 2 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: stopped early, as of the sponsor's last update on 2 Aug 2017. 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. 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 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?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: Day 1). The study lists 16 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 2 Aug 2017.