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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: TR-701 FA 200 mg

• Registration Number: NCT01496677
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Study Start: 2012-01-17
• Primary Completion: 2012-02-28
• Study Completion: 2012-02-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elderly subjects (65 or older)	TR-701 FA 200 mg	-
Younger adults (18-45 years old)	TR-701 FA 200 mg	-

Primary Outcome Measures

Name	Time	Method
Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects	28 days

Trial Locations

Locations (1)

Trius Investigator Site 001; 🇺🇸 Daytona Beach, Florida, United States