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



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:August 2012
End Date:December 2012
Contact:Claudia Fuentes
Email:Cfuentes@theravance.com
Phone:650-808-6400

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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


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.


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.
We found this trial at
1
site
8307 Gault Lane
San Antonio, Texas 78209
210-614-0062
?
mi
from
San Antonio, TX
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