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

NCT03667547 | Completed Phase 4 Results

• 2 other identifiers: 0518-851MK-0518-851
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus (HIV) Infection

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to Day 14 after dosing

• Number of Participants Discontinued From the Study Due to an 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 discontinued from the study due to an AE was reported.

  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.

  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.

  Up to Day 14 after dosing

Secondary Outcomes (7)

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

  Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

• Maximum Plasma Concentration (Cmax) of Raltegravir

  Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

• Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24)

  24 hours after dosing

• Time of Maximum Plasma Concentration (Tmax) of Raltegravir

  Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

• Apparent Plasma Half-life (t1/2) of Raltegravir

  Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

Study Arms (1)

Raltegravir

EXPERIMENTAL

Participants will receive a single oral dose of raltegravir 1200 mg (600 mg tablet X 2) in a fasted state on Day 0 and will be followed up to 2 weeks

Drug: Raltegravir

Interventions

Raltegravir DRUG

Raltegravir 600 mg tablet

Also known as: MK-0518, ISENTRESS®

Raltegravir

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 0001)

Tokyo, 171-0014, Japan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: September 27, 2018
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)