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

Merck Sharp & Dohme LLC18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Diseases, Bacterial

Interventions

midazolamDRUG

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

rosuvastatinDRUG

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

tedizolid phosphateDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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