A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)

A Multiple-Dose Study to Evaluate the Effects of Steady-State Tedizolid Phosphate Administration on the Pharmacokinetics and Safety of a Single Dose of Midazolam and Rosuvastatin

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02477514

Enrollment

Registered

2015-06-22

Start date

2015-06-30

Completion date

2015-08-31

Last updated

2015-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Diseases, Bacterial

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.

Interventions

DRUGmidazolam

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

DRUGrosuvastatin

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

DRUGtedizolid phosphate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026