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Completed

NCT Number: NCT02477514

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

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.

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Key information

Conditions

Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

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

Rosuvastatin

Drug

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

Tedizolid phosphate

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2015
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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