Phase 4
Completed N=12
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
Source: ClinicalTrials.gov NCT03667547 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With an Adverse Event (AE) — 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event (AE) |
— | — |
| PRIMARY Number of Participants Discontinued From the Study Due to an AE |
— | — |
| PRIMARY Number of Participants With a Serious Adverse Event (SAE) |
— | — |
| PRIMARY Number of Participants With a Drug-related AE |
— | — |
| SECONDARY Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir |
62.8 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Raltegravir |
20163 | — |
| SECONDARY Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24) |
74.5 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax) of Raltegravir |
1.75 | — |
| SECONDARY Apparent Plasma Half-life (t1/2) of Raltegravir |
7.50 | — |
| SECONDARY Apparent Total Plasma Clearance (CL/F) of Raltegravir |
39.6 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Raltegravir |
429 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03667547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.