Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Midazolam

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

In Part 1, all participants received a single oral dose of 2 mg midazolam on Day -2. On Days 1-5, all participants received daily single oral doses of ridaforolimus 40 mg ( 4 x 10 mg tablets). On Day 5, all participants received a single oral dose of 2 mg midazolam coadministered with the dose of ridaforolimus. Participants had the option to continue into Part 2 of this study.

A single oral dose of midazolam 2 mg (1 mL of 2 mg/mL syrup) was given on Day -2 and Day 5.

Ridaforolimus 40 mg (4 x 10 mg tablets) oral once daily on Days 1 through 5.

Ridaforolimus

The purpose of this study is to compare the pharmacokinetic profile of midazolam given alone and midazolam given after multiple oral doses of 40 mg ridaforolimus.

Part 1 of this study is designed for evaluating CYP3A4 activity following 5 days of dosing of ridaforolimus and is not designed with efficacy endpoints. Part 2 is a compassionate-use extension to give patients an opportunity to receive a clinically active dose of ridaforolimus. Part 2 dosing is open ended with limited data collection.

Effect of Ridaforolimus on the Pharmacokinetics of Midazolam (Study MK-8669-044)

A Study to Evaluate the Effect of Multiple Doses of Ridaforolimus (AP23573; MK-8669) on the Single Dose Pharmacokinetics of Midazolam.

Merck Sharp & Dohme LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Ridaforolimus on the Pharmacokinetics of Midazolam (Study MK-8669-044)	NCT01071304	Relapsed or Ref...	Midazolam Ridaforolimus	18 Years -	Merck Sharp & Dohme LLC
Effect of Ridaforolimus on the Pharmacokinetics of Midazolam (Study MK-8669-044)	NCT01071304	Relapsed or Ref...	Midazolam Ridaforolimus	18 Years -	Merck Sharp & Dohme LLC

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