Healthy VolunteersPhase 1NCT04131556

A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants

A Phase 1 study testing Maribavir in people with Healthy Volunteers, run by Shire at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The Purpose of this study is to assess the relative bioavailability, dose proportionality, the impact of food on the rate and extent of absorption, palatability of the selected pediatric formulation of maribavir and the safety and tolerability of two candidate pediatric formulations and the adult tablet formulation of… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Maribavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 25 Oct 2019to 6 Jan 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 50 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, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study.
Age 18-50 years, inclusive at the time of consent.
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.
Healthy as determined by the investigator on the basis of screening evaluations.
Hemoglobin for males greater than or equal to (> or =)135.0 gram per liter (g/L) and females > or = 120.0 g/L at screening and on Day -1.
Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m2) inclusive with a body weight greater than (>) 50 kg (110 lbs).

Who cannot join

History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder 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 investigational product or procedures.
Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
Within 30 days prior to the first dose of investigational product:a) Have used an investigational product, b) Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this study, c) Have had any substantial changes in eating habits, as assessed by the investigator.

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Confirmed systolic blood pressure >139 millimetre of mercury (mmHg) or < 89 mmHg, and diastolic blood pressure > 89 mmHg or < 49 mmHg.
Twelve-lead ECG demonstrating QTc > 450 millisecond (msec).
Known history of alcohol or other substance abuse 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 screen for alcohol or drugs of abuse at screening or on Day -1 of Treatment Period.
A positive human immunodeficiency virus (HIV), 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.
Prior screen failure, randomization, enrollment, participation in this study or participation in Part 1 of this study.
Current use of any prescription medication with the exception of hormonal replacement therapy. (Current use is defined as use within 30 days of the first dose of investigational product.) Current use of any over the counter medication (including herbal, or homeopathic preparations) within 14 days of the first dose of investigational product.
Current use of antacids and H2 antagonists.
Ingestion of known CYP3A modulators within 7 days of Day 1, Period 1.
Inability or unwillingness to consume 100 percent of high-fat meal in Part 2 (including participants with lactose or gluten intolerance).
History of 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami, Llc
Miami, Florida, 33014

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Crossover, Bioavailability, Dose Proportionality, and Food Effect Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Subjects

Read the detailed description

The study will be conducted in two parts (Part 1 and Part 2). Part 1 consists of three treatment periods in six sequences and part 2 consists of four treatment periods in four sequences. In Part 1 two pediatric candidate powder formulations will be compared with maribavir 200mg tablet under fasted conditions in regards to their bioavailability and palatability. In Part 2 dose proportionality and impact of food (a high-fat meal) on the rate and extent of absorption of the selected pediatric formulation will be assessed. The pediatric formulation which will be evaluated in Part 2 will be chosen based on the results of planned analysis of Part 1 PK and palatability data from two candidate pediatric formulations and the doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.

Conditions: Healthy Volunteers
Being tested: Maribavir

What participants receive

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

MaribavirDrug
Also called TAK620, SHP620
Participants in both part 1 and part 2 of the study will receive maribavir tablet or suspension orally depending upon the treatment sequence allocation for a total of 7 and 10 days respectively.

Study groups in NCT04131556
Study group	Role	What they receive
Part 1: Sequence ABC	Experimental	Participants will receive 200 milligram (mg) of maribavir tablet orally (Sequence A) on Day 1 followed by 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Sequence B) on Day 4 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7. Receives: Drug: Maribavir
Part 1: Sequence BCA	Experimental	Participants will receive 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 1 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 4 and followed by 200 mg of maribavir tablet orally (Sequence A) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7. Receives: Drug: Maribavir
Part 1: Sequence CAB	Experimental	Participants will receive maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 1 followed by 200 mg of maribavir tablet orally (Sequence A) on Day 4 and followed by 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7. Receives: Drug: Maribavir
Part 1: Sequence CBA	Experimental	Participants will receive maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 1 followed by 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Sequence B) on Day 4 and followed by 200 mg of maribavir tablet orally (Sequence A) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7. Receives: Drug: Maribavir
Part 1: Sequence ACB	Experimental	Participants will receive 200 mg of maribavir tablet orally (Sequence A) on Day 1 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 4 and followed by 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7. Receives: Drug: Maribavir
Part 1: Sequence BAC	Experimental	Participants will receive 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 1 followed by 200 mg of maribavir tablet orally (Sequence A) on Day 4 and followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 7 and with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7. Receives: Drug: Maribavir
Part 2: Sequence DEGF	Experimental	Participants under fast will receive 50 mg of maribavir powder for oral suspension (Sequence D) on Day 1 followed by 100 mg of maribavir powder for oral suspension (Sequence E) on Day 4 followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 7 and then followed by participants under fast will receive 200 mg of maribavir powder for oral suspension (Sequence F) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1. Receives: Drug: Maribavir
Part 2: Sequence EFDG	Experimental	Participants under fast will receive 100 mg of maribavir powder for oral suspension (Sequence E) on Day 1 followed by 200 mg of maribavir powder for oral suspension (Sequence F) on Day 4 followed by 50 mg of maribavir powder for oral suspension (Sequence D) on Day 7 and then followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1. Receives: Drug: Maribavir
Part 2: Sequence FGED	Experimental	Participants under fast will receive 200 mg of maribavir powder for oral suspension (Sequence F) on Day 1 followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 4 followed by participants under fast will receive 100 mg of maribavir powder for oral suspension (Sequence E) on Day 7 and then followed by 50 mg of maribavir powder for oral suspension (Sequence D) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1. Receives: Drug: Maribavir
Part 2: Sequence GDFE	Experimental	Participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 1 followed by participants under fast will receive 50 mg of maribavir powder for oral suspension (Sequence D) on Day 4 followed by 200 mg of maribavir powder for oral suspension (Sequence F) on Day 7 and then followed by 100 mg of maribavir powder for oral suspension (Sequence E) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1. Receives: Drug: Maribavir

What is being measured

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

Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
Cmax defined as maximum concentration occurred at tmax of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma
AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma
AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma
t1/2 of maribavir in plasma was reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7
Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma
CL/F of maribavir in Plasma was reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7
Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma
Tlag of maribavir in plasma was reported.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Day 1, 4 and 7
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
The palatability was evaluated to identify, characterize and quantify the sensory attributes of products, e.g., basic tastes, texture and mouth feel and to assess the overall acceptability. Number of participants responded to palatability assessment up to Day 7 were reported.
Measured: Up to Day 7

Secondary outcomes (4)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (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 treatment. A TEAE was an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. Number of participants with TEAEs were reported.
Measured: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
Vital sign assessments included systolic and diastolic blood pressure, pulse rate and body temperature. Any change in vital signs which were deemed clinically significant by the investigator were recorded as TEAE.
Measured: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE.
Measured: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs
Clinical laboratory tests included biochemistry, hematology and urinalysis. Any change in clinical laboratory results which are deemed clinically significant by the investigator were reported as TEAE.
Measured: From start of study drug administration up to follow-up (Day 17)

Timeline

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

25 Oct 20196 Jan 2020

First posted18 Oct 2019
Study start25 Oct 2019
Primary completion6 Jan 2020
Study completion6 Jan 2020

Why it stopped: The study was stopped because based on the planned interim analysis of the data of Part 1, palatability of both pediatric formulations was not acceptable.

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.
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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04131556
Sponsor's protocol ID: TAK-620-1019
Status last verified: Aug 2025
First submitted: 17 Oct 2019
Last updated: 2 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.

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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, Crossover, Bioavailability, Dose Proportionality, and Food Effect Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT04131556
Acronym / sponsor ID: TAK-620-1019
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped because based on the planned interim analysis of the data of Part 1, palatability of both pediatric formulations was not acceptable.
Enrolment: 20 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 25 Oct 2019 (actual)
Primary completion: 6 Jan 2020 (actual)
Study completion: 6 Jan 2020 (actual)
First posted: 18 Oct 2019 (actual)
Results: Posted 19 Jan 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Part 1: Sequence ABC	Experimental	Drug: MaribavirParticipants will receive 200 milligram (mg) of maribavir tablet orally (Sequence A) on Day 1 followed by 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Sequence B) on Day 4 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Part 1: Sequence BCA	Experimental	Drug: MaribavirParticipants will receive 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 1 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 4 and followed by 200 mg of maribavir tablet orally (Sequence A) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Part 1: Sequence CAB	Experimental	Drug: MaribavirParticipants will receive maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 1 followed by 200 mg of maribavir tablet orally (Sequence A) on Day 4 and followed by 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Part 1: Sequence CBA	Experimental	Drug: MaribavirParticipants will receive maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 1 followed by 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Sequence B) on Day 4 and followed by 200 mg of maribavir tablet orally (Sequence A) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Part 1: Sequence ACB	Experimental	Drug: MaribavirParticipants will receive 200 mg of maribavir tablet orally (Sequence A) on Day 1 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 4 and followed by 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Part 1: Sequence BAC	Experimental	Drug: MaribavirParticipants will receive 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 1 followed by 200 mg of maribavir tablet orally (Sequence A) on Day 4 and followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 7 and with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Part 2: Sequence DEGF	Experimental	Drug: MaribavirParticipants under fast will receive 50 mg of maribavir powder for oral suspension (Sequence D) on Day 1 followed by 100 mg of maribavir powder for oral suspension (Sequence E) on Day 4 followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 7 and then followed by participants under fast will receive 200 mg of maribavir powder for oral suspension (Sequence F) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Part 2: Sequence EFDG	Experimental	Drug: MaribavirParticipants under fast will receive 100 mg of maribavir powder for oral suspension (Sequence E) on Day 1 followed by 200 mg of maribavir powder for oral suspension (Sequence F) on Day 4 followed by 50 mg of maribavir powder for oral suspension (Sequence D) on Day 7 and then followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Part 2: Sequence FGED	Experimental	Drug: MaribavirParticipants under fast will receive 200 mg of maribavir powder for oral suspension (Sequence F) on Day 1 followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 4 followed by participants under fast will receive 100 mg of maribavir powder for oral suspension (Sequence E) on Day 7 and then followed by 50 mg of maribavir powder for oral suspension (Sequence D) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Part 2: Sequence GDFE	Experimental	Drug: MaribavirParticipants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 1 followed by participants under fast will receive 50 mg of maribavir powder for oral suspension (Sequence D) on Day 4 followed by 200 mg of maribavir powder for oral suspension (Sequence F) on Day 7 and then followed by 100 mg of maribavir powder for oral suspension (Sequence E) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Ability to voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study.
Age 18-50 years, inclusive at the time of consent.
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.
Healthy as determined by the investigator on the basis of screening evaluations.

Key exclusion criteria (21 listed)

History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder 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 investigational product or procedures.
Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product.

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
MaribavirAlso: TAK620, SHP620Participants in both part 1 and part 2 of the study will receive maribavir tablet or suspension orally depending upon the treatment sequence allocation for a total of 7 and 10 days respectively.	Drug	Part 1: Sequence ABC, Part 1: Sequence ACB, Part 1: Sequence BAC, Part 1: Sequence BCA, Part 1: Sequence CAB, Part 1: Sequence CBA, Part 2: Sequence DEGF, Part 2: Sequence EFDG, Part 2: Sequence FGED, Part 2: Sequence GDFE

Primary outcome

Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
Cmax defined as maximum concentration occurred at tmax of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported.
Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7
t1/2 of maribavir in plasma was reported.
Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7
CL/F of maribavir in Plasma was reported.
Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Day 1, 4 and 7
Tlag of maribavir in plasma was reported.
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Time frame: Up to Day 7
The palatability was evaluated to identify, characterize and quantify the sensory attributes of products, e.g., basic tastes, texture and mouth feel and to assess the overall acceptability. Number of participants responded to palatability assessment up to Day 7 were reported.

4 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
Time frame: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
Time frame: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs
Time frame: From start of study drug administration up to follow-up (Day 17)

Results and safety

Results posted to the registry on 19 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maribavir	20	18

Primary outcome: Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma

Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7. Geometric mean (Geometric Coefficient of Variation). Unit: Micrograms per milliliter (mcg/mL)

Measure	Treatment A n = 18	Treatment B n = 19	Treatment C n = 20
Value	10.7 (31.42)	7.35 (46.92)	6.84 (56.71)

Treatment A vs Treatment B: % Ratio of Geometric least square means: 67.76 (90% CI 59.50 to 77.16), ANOVA
Treatment A vs Treatment C: % Ratio of Geometric least squares means: 62.29 (90% CI 54.73 to 70.90), ANOVA

Population analysed: Pharmacokinetic (PK) set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.

Primary outcome: Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma

Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7. Median (Full Range). Unit: Hour

Measure	Treatment A n = 18	Treatment B n = 19	Treatment C n = 20
Value	1.00 (0.500 to 2.00)	3.00 (1.00 to 4.00)	2.00 (1.00 to 4.00)

Treatment A vs Treatment B: Median Difference (Final Values): 1.25 (90% CI 0.75 to 1.75), p <.001, Wilcoxon signed rank test
Treatment A vs Treatment C: Median Difference (Final Values): 1.00 (90% CI 0.75 to 1.25), p <.001, Wilcoxon signed rank test

Population analysed: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.

Primary outcome: Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma

Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7. Geometric mean (Geometric Coefficient of Variation). Unit: Hour*micrograms per milliliter (h*μg/mL)

Measure	Treatment A n = 18	Treatment B n = 19	Treatment C n = 20
Value	50.1 (49.21)	41.2 (55.09)	39.1 (60.58)

Treatment A vs Treatment B: % Ratio of Geometric least squares means: 81.27 (90% CI 73.88 to 89.40), ANOVA
Treatment A vs Treatment C: % Ratio of Geometric least squares means: 78.00 (90% CI 70.92 to 85.79), ANOVA

Primary outcome: Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma

Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7. Geometric mean (Geometric Coefficient of Variation). Unit: h*μg/mL

Measure	Treatment A n = 18	Treatment B n = 19	Treatment C n = 20
Value	52.5 (49.72)	44.5 (56.26)	42.4 (60.69)

Treatment A vs Treatment B: % Ratio of Geometric least squares means: 83.52 (90% CI 76.12 to 91.64), ANOVA
Treatment A vs Treatment C: % Ratio of Geometric least squares means: 80.36 (90% CI 73.26 to 88.16), ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration up to follow-up (Day 17). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maribavir	0 of 20 (0%)	3 of 20 (15%)	0 of 20

Limitations and caveats (from the sponsor): Sponsor terminated this study based on the planned interim analysis of the data of Part 1, palatability of both pediatric formulations was not acceptable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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 7 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: stopped early, as of the sponsor's last update on 2 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 19 Jan 2021). 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?

Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma (time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7). The study lists 8 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 NCT04131556.

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 2 Sep 2025.