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

Skin Diseases, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477514
• Other study ID #: 1986-004
• Secondary ID: TR701-133
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2015
• Last updated: August 21, 2015
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Diseases
• Skin Diseases, Bacterial

Intervention

Drug:
• midazolam
2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14
• rosuvastatin
10 mg tablet administered as a single oral dose on Days 3 and 16
• tedizolid phosphate
200 mg oral tablet administered once daily on Days 5-17

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No