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

Study Overview
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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).

Official Title
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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

Conditions
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Healthy, Opioid-induced Constipation

Intervention / Treatment
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* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1211 dose level 1<br>Ascending doses | Drug: TD-1211<br>* Dose level 1<br>|
| Experimental: TD-1211 dose level 2<br>Ascending doses | Drug: TD-1211<br>* Dose level 2<br>|
| Experimental: TD-1211 dose level 3<br>Ascending doses | Drug: TD-1211<br>* Dose level 3<br>|
| Experimental: TD-1211 dose level 4<br>Ascending doses | Drug: TD-1211<br>* Dose Level 4<br>|
| Experimental: TD-1211 OIC dose level 1<br>Ascending doses | Drug: TD-1211<br>* Ascending doses<br>|
| Experimental: TD-1211 OIC dose level 2<br>Ascending doses | Drug: TD-1211<br>* Ascending doses<br>|
| Experimental: TD-1211 OIC dose level 3<br>Ascending doses | Drug: TD-1211<br>* Ascending doses<br>|
| Experimental: TD-1211 OIC dose level 4<br>Ascending doses | Drug: TD-1211<br>* Ascending doses<br>|
| Experimental: TD-1211 OIC dose level 5<br>Ascending doses | Drug: TD-1211<br>* Ascending doses<br>|
| Placebo Comparator: Placebo<br>Ascending doses | Drug: Placebo<br>* Ascending doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects