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

NCT ID: NCT01040637

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Opioid-induced Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TD-1211 dose level 1

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Dose level 1

TD-1211 dose level 2

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Dose level 2

TD-1211 dose level 3

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Dose level 3

TD-1211 dose level 4

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Dose Level 4

TD-1211 OIC dose level 1

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Ascending doses

TD-1211 OIC dose level 2

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Ascending doses

TD-1211 OIC dose level 3

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Ascending doses

TD-1211 OIC dose level 4

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Ascending doses

TD-1211 OIC dose level 5

Ascending doses

Group Type EXPERIMENTAL

TD-1211

Intervention Type DRUG

Ascending doses

Placebo

Ascending doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ascending doses

Interventions

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TD-1211

Dose level 1

Intervention Type DRUG

TD-1211

Dose level 2

Intervention Type DRUG

TD-1211

Dose level 3

Intervention Type DRUG

TD-1211

Dose Level 4

Intervention Type DRUG

TD-1211

Ascending doses

Intervention Type DRUG

TD-1211

Ascending doses

Intervention Type DRUG

TD-1211

Ascending doses

Intervention Type DRUG

TD-1211

Ascending doses

Intervention Type DRUG

TD-1211

Ascending doses

Intervention Type DRUG

Placebo

Ascending doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Theravance Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

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Clinical Research Unit

Pasadena, California, United States

Site Status

Clinical Research Unit

San Antonio, Texas, United States

Site Status

Clinical Research Unit

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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0067

Identifier Type: -

Identifier Source: org_study_id

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