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NCT01496677 Clinical Trial

Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects

Healthy Subjects Clinical Trial

Official title:
A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01496677
Other study ID # 1986-028
Secondary ID TR701-109
Status Completed
Phase Phase 1
First received December 19, 2011
Last updated October 4, 2017
Start date January 17, 2012
Est. completion date February 28, 2012

Study information
Verified date October 2017
Source Trius Therapeutics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

Description:

This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date February 28, 2012
Est. primary completion date February 28, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive

- BMI =18.0 kg/m2 and =35.0 kg/m2

Elderly Group

- Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)

Control Group

- Medically stable with no clinically significant abnormalities

Exclusion Criteria:

- Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)

- Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result

- Previous inclusion in a TR-701 FA or TR-701 clinical study

- ECG finding of QTc interval >500 msec, or other clinically significant ECG abnormality at Screening

- Female subjects whom are pregnant, lactating or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TR-701 FA 200 mg
Single oral tablet of TR-701 FA to elderly subjects
• TR-701 FA 200 mg
Single oral tablet of TR-701 FA to younger group (18-45 years old)

Locations
Country Name City State
United States Trius Investigator Site 001 Daytona Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects 28 days
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