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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01655771
First received: July 31, 2012
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Constipation
Drug: TD-1211 Dose 1
Drug: TD-1211 Dose 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Cmax [ Time Frame: 0-96 hours ] [ Designated as safety issue: No ]
  • AUCt [ Time Frame: Based on samples collected 0-96 hours ] [ Designated as safety issue: No ]
  • AUCinf [ Time Frame: Based on samples collected 0-96 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with treatment-emergent adverse events [ Time Frame: Days 1-14 ] [ Designated as safety issue: Yes ]
  • Number patients with abnormal vital sign measurements [ Time Frame: Days 1-5 ] [ Designated as safety issue: Yes ]
  • Number of patients with abnormal clinical laboratory results [ Time Frame: Days 1-5 ] [ Designated as safety issue: Yes ]
  • Number of patients with abnormal corrected QTc interval [ Time Frame: Days 1-5 ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: August 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly
TD-1211 Dose 1
Drug: TD-1211 Dose 1
Experimental: Younger
TD-1211 Dose 2
Drug: TD-1211 Dose 2

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655771

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

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier: NCT01655771     History of Changes
Other Study ID Numbers: 0083
Study First Received: July 31, 2012
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Opioid induced constipation
Constipation

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

ClinicalTrials.gov processed this record on August 19, 2014