NCT01539473

Brief Summary

Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

February 21, 2012

Last Update Submit

May 2, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure

    14 days

Study Arms (2)

TR-701 FA with Tyramine

EXPERIMENTAL

TR-701 FA 200 oral with Tyramine

Drug: TR-701 FA with Tyramine

Placebo-controlled with Tyramine

PLACEBO COMPARATOR

Placebo-controlled with Tyramine

Drug: Placebo-controlled withTyramine

Interventions

TR-701 FA with TyramineDRUG

TR-701 FA 200 mg oral and Tyramine

Also known as: Tedizolid Phosphate
TR-701 FA with Tyramine
Placebo-controlled withTyramineDRUG

Placebo-controlled and Tyramine

Placebo-controlled with Tyramine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects between 18 to 45 years of age, inclusive
  • Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
  • Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,

You may not qualify if:

  • Systolic blood pressure \>130 mmHg or \<90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
  • Heart rate \>90 bpm or \<45 bpm measured after 10 minutes in the supine position
  • Electrocardiogram (ECG) finding of QTc interval \>500 msec, or other clinically significant ECG abnormality at the Screening Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trius Investigator Site 001

Evansville, Indiana, 47710, United States

Location

Related Publications (1)

  • Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.

    PMID: 23612197DERIVED

MeSH Terms

Interventions

Tyraminetedizolid phosphate

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic Chemicals

Study Officials

  • Philippe G Prokocimer, MD

    Trius Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

US(1)