MedDataX Logo

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

NCT ID: NCT01496677

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-17

Study Completion Date

2012-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elderly subjects (65 or older)

Group Type EXPERIMENTAL

TR-701 FA 200 mg

Intervention Type DRUG

Single oral tablet of TR-701 FA to elderly subjects

Younger adults (18-45 years old)

Group Type EXPERIMENTAL

TR-701 FA 200 mg

Intervention Type DRUG

Single oral tablet of TR-701 FA to younger group (18-45 years old)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TR-701 FA 200 mg

Single oral tablet of TR-701 FA to elderly subjects

Intervention Type DRUG

TR-701 FA 200 mg

Single oral tablet of TR-701 FA to younger group (18-45 years old)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe G Prokocimer, MD

Role: STUDY_CHAIR

Trius Therapeutics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trius Investigator Site 001

Daytona Beach, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Flanagan SD, Minassian SL, Prokocimer P. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects. Clin Pharmacol Drug Dev. 2018 Sep;7(7):788-794. doi: 10.1002/cpdd.426. Epub 2018 Jan 10.

Reference Type DERIVED
PMID: 29319932 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TR701-109

Identifier Type: OTHER

Identifier Source: secondary_id

1986-028

Identifier Type: -

Identifier Source: org_study_id