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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: TD-1211 Dose 1; Drug: TD-1211 Dose 2

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Development Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	0-96 hours
AUCt	Based on samples collected 0-96 hours
AUCinf	Based on samples collected 0-96 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Glycyx Therapeutics
• Collaborators: Theravance Biopharma
• Investigators: Study Director: Medical Monitor, Theravance Biopharma

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimated): August 2, 2012

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Constipation; Opioid induced constipation
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Signs and Symptoms, Digestive; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Induced Constipation; Constipation
• Other Study ID Numbers: 0083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No