Maribavir drug study compares japanese and caucasian adults

NCT ID NCT04497883

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This early-stage study tested a single dose of the drug maribavir in 24 healthy adults—12 of Japanese descent and 12 of non-Hispanic Caucasian descent. The goal was to see if the drug behaves differently in these groups and to check safety. Participants took different doses to understand how the body processes the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
maribavir

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Aug 2020

Finished

Nov 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * An understanding, ability, and willingness to fully comply with study procedures and restrictions. * Ability to voluntarily provide written informed consent/assent as applicable to participate in the study. * Healthy 18 to 55 years old participants of Japanese descent and non-Hispanic Caucasian origin. * Healthy participants of Japanese descent must have been born in Japan and must not have lived outside of Japan for greater than (\>) 10 years; both parents and all 4 grandparents must be of Japanese origin. Healthy, non-Hispanic, Caucasian participants must have both parents and all 4 grandparents of non-Hispanic, Caucasian origin. * Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. * Hemoglobin for males greater than or equal to (\>=) 135.0 gram per liter (g/L) and females \>= 120.0 g/L at screening and on Day -1. * Body mass index (BMI) between 18.5 and 28.0 kilogram per square meter (kg/m\^2) inclusive with a body weight \> 45 kilograms (kg) (99 pounds \[lbs\]). * Ability to swallow a dose of investigational product (IP). Exclusion Criteria: * History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current recurrent disease. * Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures. * Known or suspected intolerance or hypersensitivity to maribavir, closely-related compounds, or any of the stated ingredients. * Significant illness, as judged by the investigator, within 2 weeks of the first dose of IP. * Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the first dose of IP. * Have taken another IP within 30 days or five half-lives of that IP, whichever is greater, prior to the first dose of maribavir. * Have been enrolled in a clinical study (including vaccine studies) within 30 days prior to the first dose of IP that, in the investigator's opinion, may impact this study. * Have had any substantial changes in eating habits within 30 days prior to the first dose of IP, as assessed by the investigator. * Confirmed systolic blood pressure \> 139 millimeter of mercury (mmHg) or less than (\<) 89 mmHg, and diastolic blood pressure \> 89 mmHg or \< 49 mmHg. * Twelve-lead ECG demonstrating QTc \> 450 milliseconds (msec). * Known history of alcohol or other substance abuse, including synthetic cannabinoids within the last year. * Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. * A positive urine test for drugs of abuse, alcohol, or cotinine at screening or on Day -1. * A positive human immunodeficiency virus (HIV), hepatitis B surface antibody (HBsAg), or hepatitis C virus (HCV) antibody screen. * Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch). * Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. * Current use of any prescription medication within 30 days of the first dose of IP. Current use of any over the counter medication within 14 days of the first dose of IP. * Ingestion of known cytochrome P450 (CYP) 3A modulators within 7 days of Day 1, period 1 * History of active or chronic oral/nasal cavity infections, gastroesophageal reflux, asthma treatment with albuterol, zinc supplementation. * Participants with dry mouth syndrome or burning mouth syndrome or menopausal women suffering from dysgeusia. * Participants who have acute gastrointestinal (GI) symptoms at screening or admission (e.g. nausea, vomiting, diarrhea, and heartburn).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • PPD Development, LP

    Las Vegas, Nevada, 89113, United States

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