A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)

PHASE1CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

December 31, 2005

Study Completion Date

January 31, 2006

Conditions
Chemotherapy-Induced Nausea and VomitingPostoperative Nausea and Vomiting
Interventions
DRUG

90 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes

DRUG

100 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

DRUG

100 MK-0517 (PS80) + 2 mg midazolam

MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.

DRUG

115 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

DRUG

150 mg MK-0517 (PS80)

MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes

DRUG

40 mg MK-0517 (non-PS80)

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

DRUG

100 mg MK-0517 (non-PS80)

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

DRUG

150 mg MK-0517 (Non-PS80)

MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.

DRUG

Placebo

Placebo matching MK-0517

DRUG

40 mg Aprepitant

Aprepitant, oral, tablet, single dose

DRUG

125 mg Aprepitant

Aprepitant oral tablet, single dose

DRUG

2 mg Midazolam

Midazolam oral tablet, single dose

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00990821 - A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012) | Biotech Hunter | Biotech Hunter