TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.

Official Title
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A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of TD-1211 Administered Orally to Elderly and Young Healthy Subjects

Conditions
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Constipation

Intervention / Treatment
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* Drug: TD-1211 Dose 1
* Drug: TD-1211 Dose 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive. Body mass index (BMI) should be 18 to 36 kg/m2, inclusive. At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supine systolic and diastolic blood pressure of 90 to 150 mm Hg and 50 to 90 mm Hg, respectively (2 of 3 measurements) Subjects with mild, chronic, stable disease (e.g., controlled hypertension, non-insulin-dependent diabetes, arthritis) may be enrolled if deemed medically acceptable by the investigator Negative for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus antibody within the last 3 months No clinically relevant abnormalities in laboratory evaluations Exclusion Criteria: History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if condition is well controlled and not anticipated to interfere with the objectives of the study. Any clinically significant abnormal ECG (electrocardiogram). Participation in another clinical trial of an investigational drug or medical device within 60 days. Donation of ≥500 mL blood, or equivalent, within 8 weeks prior to admission day. Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety, tolerability, or PK of the investigational drug or prevent compliance with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly<br>TD-1211 Dose 1 | Drug: TD-1211 Dose 1<br> <br> |
| Experimental: Younger<br>TD-1211 Dose 2 | Drug: TD-1211 Dose 2<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 0-96 hours | 
| AUCt |  | Based on samples collected 0-96 hours | 
| AUCinf |  | Based on samples collected 0-96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-emergent adverse events |  | Days 1-14 | 
| Number patients with abnormal vital sign measurements |  | Days 1-5 | 
| Number of patients with abnormal clinical laboratory results |  | Days 1-5 | 
| Number of patients with abnormal corrected QTc interval |  | Days 1-5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid induced constipation, Constipation