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NCT01644240 · ClinicalTrials.gov registry record · Phase 1
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, sponsored by Theravance Biopharma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01644240: Clinical Trial Phase 1 study, sponsored by Theravance Biopharma.
NCT01644240 is a Phase 1 study that was terminated before completion, run by Theravance Biopharma. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644240, a Phase 1 study, was terminated before completion, sponsored by Theravance Biopharma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Maximum concentration in plasma following dosing on Day 1
Interventions
- DRUG TD-8954
- DRUG Placebo - saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Why NCT01644240 stopped before completion
NCT01644240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which TD-8954 is the first listed.
NCT01644240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01644240 about?
NCT01644240 is a clinical study titled "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". 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...
What is the current status of trial NCT01644240?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01644240?
The interventions under investigation include: TD-8954 (DRUG), Placebo - saline (DRUG).
Who is sponsoring clinical trial NCT01644240?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01644240's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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