Healthy VolunteersPhase 1NCT04497883

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants

A Phase 1 study testing Maribavir (400 mg), Maribavir (200 mg) and Maribavir (800 mg) in people with Healthy Volunteers, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability of maribavir administered as a single oral dose in healthy, adult participants of Japanese descent and matched, healthy, adult, non-Hispanic, Caucasian participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Maribavir (400 mg), Maribavir (200 mg) and Maribavir (800 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2020to 12 Nov 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Show all 21Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development, LP
Las Vegas, Nevada, 89113

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Subjects Compared With Matched, Healthy, Non-Hispanic, Caucasian Subjects and to Assess Dose-Proportionality of 3 Doses of Maribavir in the Japanese Subjects

Read the detailed description

The study will be conducted in two cohorts, Cohort A and Cohort B. Cohort A consists of 12 participants of Japanese Descent. Cohort B consists of 12 non-Hispanic, Caucasian participants.

For Japanese participants there will be three treatment periods. In Treatment Period 1, they will receive maribavir as a single 400 mg oral dose. In Treatment Periods 2 and 3, all Japanese participants will receive maribavir as a single oral dose of either 200 mg or 800 mg, depending upon randomization assignment. For the non-Hispanic, Caucasian group there will be only one treatment period and they will receive maribavir as a single 400 mg oral dose.

Conditions: Healthy Volunteers
Being tested: Maribavir (400 mg), Maribavir (200 mg), Maribavir (800 mg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Maribavir (400 mg)Drug
Also called SHP620, TAK-620
Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
Maribavir (200 mg)Drug
Also called SHP620, TAK-620
Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
Maribavir (800 mg)Drug
Also called SHP620, TAK-620
Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.

Study groups in NCT04497883
Study group	Role	What they receive
Cohort A: Non-Hispanic, Caucasian	Experimental	Non-Hispanic, Caucasian group participants will receive 400 milligram (mg) maribavir tablets orally once on Day 1 during treatment period 1. Receives: Drug: Maribavir (400 mg)
Cohort B: Japanese Descent	Experimental	Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1 followed by 200 mg or 800 mg maribavir tablets orally once on Day 1 during treatment period 2 followed by 800 mg or 200 mg maribavir tablets orally once on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours will be maintained between treatment period 1, 2, and 3. Receives: Drug: Maribavir (400 mg); Drug: Maribavir (200 mg); Drug: Maribavir (800 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Maribavir
Cmax of maribavir in plasma were reported.
Measured: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
AUClast of maribavir in plasma were reported.
Measured: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir
AUC(0-infinity) of maribavir in plasma were reported.
Measured: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Secondary outcomes (4)

Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants
Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.
Measured: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants
Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.
Measured: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants
Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.
Measured: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.
Measured: From start of study drug administration to follow-up (up to Day 23)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 202012 Nov 2020

First posted4 Aug 2020
Study start7 Aug 2020
Primary completion12 Nov 2020
Study completion12 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04497883
Sponsor's protocol ID: TAK-620-1020
Status last verified: Sep 2025
First submitted: 7 Jul 2020
Last updated: 11 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.

Publications

Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
PubMed 41121745

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Subjects Compared With Matched, Healthy, Non-Hispanic, Caucasian Subjects and to Assess Dose-Proportionality of 3 Doses of Maribavir in the Japanese Subjects
ClinicalTrials.gov ID: NCT04497883
Acronym / sponsor ID: TAK-620-1020
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 7 Aug 2020 (actual)
Primary completion: 12 Nov 2020 (actual)
Study completion: 12 Nov 2020 (actual)
First posted: 4 Aug 2020 (actual)
Results: Posted 8 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted in two cohorts, Cohort A and Cohort B. Cohort A consists of 12 participants of Japanese Descent. Cohort B consists of 12 non-Hispanic, Caucasian participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A: Non-Hispanic, Caucasian	Experimental	Drug: Maribavir (400 mg)Non-Hispanic, Caucasian group participants will receive 400 milligram (mg) maribavir tablets orally once on Day 1 during treatment period 1.
Cohort B: Japanese Descent	Experimental	Drug: Maribavir (400 mg), Drug: Maribavir (200 mg), Drug: Maribavir (800 mg)Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1 followed by 200 mg or 800 mg maribavir tablets orally once on Day 1 during treatment period 2 followed by 800 mg or 200 mg maribavir tablets orally once on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours will be maintained between treatment period 1, 2, and 3.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Maribavir (400 mg)Also: SHP620, TAK-620Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.	Drug	Cohort A: Non-Hispanic, Caucasian, Cohort B: Japanese Descent
Maribavir (200 mg)Also: SHP620, TAK-620Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.	Drug	Cohort B: Japanese Descent
Maribavir (800 mg)Also: SHP620, TAK-620Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.	Drug	Cohort B: Japanese Descent

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Maribavir
Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Cmax of maribavir in plasma were reported.
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
AUClast of maribavir in plasma were reported.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir
Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
AUC(0-infinity) of maribavir in plasma were reported.

4 secondary outcomes

Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants
Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants
Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants
Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of study drug administration to follow-up (up to Day 23)

Results and safety

Results posted to the registry on 8 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Non-Hispanic, Caucasian	12	12
Cohort B: Japanese Descent: Maribavir 400mg	12	12
Cohort B: Japanese Descent: First Maribavir 200 mg Then Maribavir 800 mg	0	0
Cohort B: Japanese Descent: First Maribavir 800 mg Then Maribavir 200 mg	0	0

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Maribavir

Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: Micrograms per milliliter (mcg/mL)

Measure	Cohort A: Maribavir 400 mg n = 12	Cohort B: Maribavir 400 mg n = 12	Cohort B: Maribavir 200 mg n = 12	Cohort B: Maribavir 800 mg n = 12
Value	15.8 (26.6)	17.4 (27.4)	9.03 (34.0)	26.3 (30.7)

Cohort A: Maribavir 400 mg vs Cohort B: Maribavir 400 mg: % Ratio of Geometric least square means: 110.41 (90% CI 91.70 to 132.94), ANOVA

Population analysed: The pharmacokinetic (PK) set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir

Measure	Cohort A: Maribavir 400 mg n = 12	Cohort B: Maribavir 400 mg n = 12	Cohort B: Maribavir 200 mg n = 12	Cohort B: Maribavir 800 mg n = 12
Value	75.3 (33.6)	92.3 (35.3)	41.3 (40.8)	183 (40.6)

Cohort A: Maribavir 400 mg vs Cohort B: Maribavir 400 mg: % Ratio of Geometric least square means: 122.49 (90% CI 96.83 to 154.95), ANOVA

Population analysed: The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir

Time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: h*mcg/mL

Measure	Cohort A: Maribavir 400 mg n = 12	Cohort B: Maribavir 400 mg n = 12	Cohort B: Maribavir 200 mg n = 12	Cohort B: Maribavir 800 mg n = 12
Value	77.3 (34.7)	96.7 (37.1)	43.0 (42.4)	195 (43.9)

Cohort A: Maribavir 400 mg vs Cohort B: Maribavir 400 mg: % Ratio of Geometric least square means: 125.08 (90% CI 97.99 to 159.64), ANOVA

Population analysed: The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration to follow-up (up to Day 23). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Maribavir 400 mg	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Cohort B: Maribavir 400 mg	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Cohort B: Maribavir 200 mg	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Cohort B: Maribavir 800 mg	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41121745Shin E, Bhat AG, Ramanathan M. Large Language Models for Clinical Trial Protocol Assessments. Clin Pharmacol Ther. 2026 Feb;119(2):393-402. doi: 10.1002/cpt.70096. Epub 2025 Oct 21.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Shire

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Maribavir (400 mg), Maribavir (200 mg) and Maribavir (800 mg) in people with Healthy Volunteers, run by Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Maribavir (time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04497883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.