Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects
This study has been completed.
Sponsor:
Trius Therapeutics, Inc.
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01496677
First received: December 19, 2011
Last updated: June 1, 2012
Last verified: December 2011
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Purpose
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects |
Drug: TR-701 FA 200 mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects |
Further study details as provided by Trius Therapeutics, Inc.:
Primary Outcome Measures:
- Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 28 |
| Study Start Date: | December 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Elderly subjects (65 or older) |
Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to elderly subjects
|
| Experimental: Younger adults (18-45 years old) |
Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to younger group (18-45 years old)
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496677
Locations
| United States, Florida | |
| Trius Investigator Site 001 | |
| Daytona Beach, Florida, United States, 32117 | |
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
| Study Chair: | Philippe G Prokocimer, MD | Trius Therapeutics |
More Information
No publications provided
| Responsible Party: | Trius Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01496677 History of Changes |
| Other Study ID Numbers: | TR701-109 |
| Study First Received: | December 19, 2011 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on June 17, 2013