NCT01040637

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

December 22, 2009

Last Update Submit

January 15, 2021

Conditions

HealthyOpioid-induced Constipation

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation

    Daily pre and post dose assessments throughout the duration of the study period

Secondary Outcomes (1)

  • Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration

    Daily pre and post dose assessments throughout the duration of the study period

Study Arms (10)

TD-1211 dose level 1

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 dose level 2

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 dose level 3

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 dose level 4

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 OIC dose level 1

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 OIC dose level 2

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 OIC dose level 3

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 OIC dose level 4

EXPERIMENTAL

Ascending doses

Drug: TD-1211

TD-1211 OIC dose level 5

EXPERIMENTAL

Ascending doses

Drug: TD-1211

Placebo

PLACEBO COMPARATOR

Ascending doses

Drug: Placebo

Interventions

TD-1211DRUG

Dose level 1

TD-1211 dose level 1
PlaceboDRUG

Ascending doses

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 18 and 65 years of age, inclusive
  • Healthy subjects and subjects with documented OIC on stable opioid regimen
  • Willingness to stop all laxatives throughout the OIC screening and treatment period

You may not qualify if:

  • Any clinically significant finding in healthy subjects
  • Have participated in another clinical trial of an investigational drug 30 days prior to screening
  • History of chronic constipation prior to opioid therapy in OIC subjects
  • Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Research Unit

Pasadena, California, 91105, United States

Location

Clinical Research Unit

San Antonio, Texas, 78209, United States

Location

Clinical Research Unit

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide

Condition Hierarchy (Ancestors)

ConstipationSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 29, 2009

Study Start

January 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

US(3)