Clinical trial NCT01655771: TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Constipation
Keywords: Opioid induced constipation
Constipation
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Cmax
timeFrame: 0-96 hours
measure: AUCt
timeFrame: Based on samples collected 0-96 hours
measure: AUCinf
timeFrame: Based on samples collected 0-96 hours
Secondary outcomes:
measure: Number of patients with treatment-emergent adverse events
timeFrame: Days 1-14
measure: Number patients with abnormal vital sign measurements
timeFrame: Days 1-5
measure: Number of patients with abnormal clinical laboratory results
timeFrame: Days 1-5
measure: Number of patients with abnormal corrected QTc interval
timeFrame: Days 1-5
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Development Solutions
state: Texas
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: