NCT01040637

A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation

A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).

Conditions

• Healthy
• Opioid-induced Constipation

Interventions

Type	Name	Description
DRUG	TD-1211	Dose level 1
DRUG	TD-1211	Dose level 2
DRUG	TD-1211	Dose level 3
DRUG	TD-1211	Dose Level 4
DRUG	TD-1211	Ascending doses
DRUG	TD-1211	Ascending doses
DRUG	TD-1211	Ascending doses
DRUG	TD-1211	Ascending doses
DRUG	TD-1211	Ascending doses
DRUG	Placebo	Ascending doses

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-12-29
• Last updated: 2021-01-20

Locations

3 sites across 1 country: United States