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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Skin Diseases, Bacterial

Treatments: Drug: midazolam; Drug: rosuvastatin; Drug: tedizolid phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477514

1986-004

TR701-133 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Experimental Arm

Experimental group

Description:

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)

Treatment:

Drug: rosuvastatin

Drug: tedizolid phosphate

Drug: midazolam