Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)

Merck Sharp & Dohme LLC12 enrolled

Overview

This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Human Immunodeficiency Virus (HIV) Infection

Interventions

RaltegravirDRUG

Raltegravir 600 mg tablet

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese male in good health * Body mass index (BMI) between 18.5 and 32.0 kg/m\^2 * Nonsmoker and has not used nicotine-containing products for over 3 months at the time of screening test. Exclusion Criteria: * History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or neurological (including cerebrovascular stroke and epilepsy) abnormalities or diseases * Significant emotional problem at the time of screening test or suspected to occur during the conduct of the study, or has a history of clinically significant psychiatric disorder within the last 5 years * History of malignancy * History of clinically significant allergies to multiple antigens or severe allergies (e.g., food, drug, and latex \[natural rubber\] allergies), or has had an anaphylactic reaction or significant intolerability (e.g., systemic allergic reaction) to prescription or non-prescription drugs or food * Positive for hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis, or HIV antigen or antibody on the screening test * Had surgery or donated or lost blood within 4 weeks prior to the screening test * Participated in another study (clinical trial) within 4 months prior to the screening test * Consumes greater than 3 glasses of alcoholic beverages (definition of 1 glass: 354 mL for beer, 118 mL for wine, 29.5 mL for distilled spirits) per day * Consumes greater than 6 servings (definition of 1 serving: equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day * Regular user of cannabis, any illicit drugs, or has a history of drug or alcohol abuse within 2 years at the time of the screening test. Participants must have a negative predose urine drug screen * Unable to consent to refrain from the consumption of citrus beverages and foods (e.g., grapefruits) beginning 2 weeks prior to administration of the study drug until the end of post-study examination, and the consumption of all fruit beverages and foods for 24 hours predose and after dosing * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is study site or Sponsor staff directly involved with this study.

Locations (1)

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 0001)

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants with an AE was reported.

Time frame: Up to Day 14 after dosing

Number of Participants Discontinued From the Study Due to an AE

Time frame: Up to Day 14 after dosing

Number of Participants With a Serious Adverse Event (SAE)

A SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly or birth defect, is another medically important event, is a new cancer, or is an overdose. The number of participants with an SAE was reported.

Time frame: Up to Day 14 after dosing

Number of Participants With a Drug-related AE

The number of participants with a drug-related AE was reported. Causality was be determined by the investigator.

Time frame: Up to Day 14 after dosing

Secondary Outcomes

Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of plasma raltegravir was calculated based on natural log-transformed values.

Data from ClinicalTrials.gov

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