drugset / Trial / NCT01644240

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

NCT01644240

Phase 1 Terminated 16 enrolled Theravance Biopharma
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2012-09
Primary completion
2012-11
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject felcisetrag Small molecule Intravenous