NCT02477514

Brief Summary

The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

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

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

June 17, 2015

Last Update Submit

August 21, 2015

Conditions

Skin Diseases, Bacterial

Outcome Measures

Primary Outcomes (6)

  • Area under the concentration versus time curve, from 0 to last observed/measured non-zero concentration (AUC0-t) of midazolam alone or in combination with tedizolid phosphate

    Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours

  • AUC0-t of rosuvastatin alone or in combination with tedizolid phosphate

    Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours

  • Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of midazolam alone or in combination with tedizolid phosphate

    Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours

  • AUC0-inf of rosuvastatin alone or in combination with tedizolid phosphate

    Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours

  • Maximum observed plasma concentration (Cmax) of midazolam alone or in combination with tedizolid phosphate

    Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours

  • Cmax of rosuvastatin alone or in combination with tedizolid phosphate

    Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg)

Drug: midazolamDrug: rosuvastatinDrug: tedizolid phosphate

Interventions

midazolamDRUG

2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14

Experimental Arm
rosuvastatinDRUG

10 mg tablet administered as a single oral dose on Days 3 and 16

Experimental Arm
tedizolid phosphateDRUG

200 mg oral tablet administered once daily on Days 5-17

Experimental Arm

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, adult males or females (women of non-childbearing potential)
  • continuous non-smokers who have not used nicotine-containing products for the previous 3 months

You may not qualify if:

  • mentally or legally incapacitated or has significant emotional problems
  • history or presence of clinically significant medical or psychiatric condition or disease
  • history or presence of alcoholism or drug abuse within the past 2 years
  • female participants who are pregnant, lactating, or of childbearing potential
  • donated blood or had significant blood loss within 56 days prior to first dose of study drug
  • plasma donation within 7 days prior to first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin Diseases, Bacterial

Interventions

MidazolamRosuvastatin Calciumtedizolid phosphate

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 22, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08