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

NCT01040637 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Glycyx Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01040637 on ClinicalTrials.gov