Clinical trial NCT03667547: Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
Official title: An Open-label Single Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-0518 1200 mg (600 mg Tablet × 2) in Healthy Japanese Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus (HIV) Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to Day 14 after dosing
measure: Number of Participants Discontinued From the Study Due to an AE
timeFrame: Up to Day 14 after dosing
measure: Number of Participants With a Serious Adverse Event (SAE)
timeFrame: Up to Day 14 after dosing
measure: Number of Participants With a Drug-related AE
timeFrame: Up to Day 14 after dosing
Secondary outcomes:
measure: Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing
measure: Maximum Plasma Concentration (Cmax) of Raltegravir
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing
measure: Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24)
timeFrame: 24 hours after dosing
measure: Time of Maximum Plasma Concentration (Tmax) of Raltegravir
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing
measure: Apparent Plasma Half-life (t1/2) of Raltegravir
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing
measure: Apparent Total Plasma Clearance (CL/F) of Raltegravir
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing
measure: Apparent Volume of Distribution (Vz/F) of Raltegravir
timeFrame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 0001)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: