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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 is a Phase 1 study that was terminated before completion, run by Theravance Biopharma. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01644240
The ClinicalTrials.gov registry entry for NCT01644240 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravance Biopharma, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TD-8954 is the first listed.
NCT01644240 reports 0 study locations.
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.
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