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

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655771
• Other study ID #: 0083
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• TD-1211 Dose 1

• TD-1211 Dose 2

Locations

Country	Name	City	State
United States	ICON Development Solutions	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		0-96 hours
Primary	AUCt		Based on samples collected 0-96 hours
Primary	AUCinf		Based on samples collected 0-96 hours
Secondary	Number of patients with treatment-emergent adverse events		Days 1-14
Secondary	Number patients with abnormal vital sign measurements		Days 1-5
Secondary	Number of patients with abnormal clinical laboratory results		Days 1-5
Secondary	Number of patients with abnormal corrected QTc interval		Days 1-5