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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01655771
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Constipation Drug: TD-1211 Dose 1 Drug: TD-1211 Dose 2 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Primary Completion Date : February 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Elderly
TD-1211 Dose 1
Drug: TD-1211 Dose 1
Experimental: Younger
TD-1211 Dose 2
Drug: TD-1211 Dose 2


Outcome Measures

Primary Outcome Measures :
  1. Cmax [ Time Frame: 0-96 hours ]
  2. AUCt [ Time Frame: Based on samples collected 0-96 hours ]
  3. AUCinf [ Time Frame: Based on samples collected 0-96 hours ]

Secondary Outcome Measures :
  1. Number of patients with treatment-emergent adverse events [ Time Frame: Days 1-14 ]
  2. Number patients with abnormal vital sign measurements [ Time Frame: Days 1-5 ]
  3. Number of patients with abnormal clinical laboratory results [ Time Frame: Days 1-5 ]
  4. Number of patients with abnormal corrected QTc interval [ Time Frame: Days 1-5 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655771


Locations
United States, Texas
ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT01655771     History of Changes
Other Study ID Numbers: 0083
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Theravance Biopharma R & D, Inc.:
Opioid induced constipation
Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms