NCT01655771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 22, 2026

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

July 31, 2012

Last Update Submit

May 19, 2026

Conditions

Constipation

Keywords

Opioid induced constipationConstipation

Outcome Measures

Primary Outcomes (3)

  • Cmax

    0-96 hours

  • AUCt

    Based on samples collected 0-96 hours

  • AUCinf

    Based on samples collected 0-96 hours

Secondary Outcomes (4)

  • 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

Study Arms (2)

Elderly

EXPERIMENTAL

TD-1211 Dose 1

Drug: TD-1211 Dose 1

Younger

EXPERIMENTAL

TD-1211 Dose 2

Drug: TD-1211 Dose 2

Interventions

TD-1211 Dose 1DRUG
Elderly
TD-1211 Dose 2DRUG
Younger

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Development Solutions

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

ConstipationOpioid-Induced Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 2, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

May 22, 2026

Record last verified: 2021-01

Locations

US(1)