Healthy VolunteersPhase 1NCT05918822

A Study of Maribavir Pediatric Formulation in Healthy Adult Participants

A Phase 1 study testing Maribavir Commercial Tablet Formulation, Maribavir Pediatric Powder-for-oral Suspension Formulation and Rabeprazole in people with Healthy Volunteers, run by Takeda 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 study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part. The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in the digestive tract compared to commercial tablet formulation and to check how a high-fat… 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 Commercial Tablet Formulation, Maribavir Pediatric Powder-for-oral Suspension Formulation and Rabeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 25 Jul 2023to 1 Sep 2023
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 and to voluntarily sign (personally or via a legally authorized representative) informed consent form to participate in the study.
Age 18 to 55 years, inclusive at the time of consent, at the screening visit.
Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or female of non-childbearing potential.
Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive with a body weight greater than (>) 50 kilograms (kg) (110 pounds [lbs]), at the screening visit.
Healthy as determined by the Investigator or designee on the basis of screening evaluations and medical history.
Hemoglobin for males greater than or equal to (>=) 135.0 gram per liter (g/L) and females >=120.0 g/L, at the screening visit and on Day -1 of Treatment Period 1.
Ability to swallow a dose of maribavir or rabeprazole.

Who cannot join

History or presence of gastritis, gastrointestinal (GI) tract disorder, hepatic disorder or cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in the opinion of the investigator or designee, may affect the absorption, distribution, metabolism, or elimination of the study drugs.
History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current recurrent disease that could affect the action, absorption, or disposition of the study drugs, or clinical or laboratory assessments.
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 study drugs or procedures.
Known or suspected intolerance or hypersensitivity to maribavir or rabeprazole (Part 2 only), closely related compounds, or any of the stated ingredients and excipients.
Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose of the investigational drug (ID).
Has diarrhea within 4 hours of the first dose of the ID.

Show all 26Show fewer

Donation of blood or blood products (example, plasma or platelets) within 60 days prior to receiving the first dose of the ID.
Within 30 days prior to the first dose of the ID:
Have used any investigational product (if elimination half-life is less than [<] 6 days, otherwise 5 half-lives).
Have been enrolled in a clinical study (including vaccine studies) that, in the Investigator or designee's opinion, may impact this Takeda-sponsored study.
Have had any substantial changes in eating habits, as assessed by the Investigator or designee.
Systolic blood pressure >140 millimeters of mercury (mmHg) or <90 mmHg, and/or diastolic blood pressure >90 mmHg or <50 mmHg, at the screening visit.
Corrected QT interval (QTc) >450 millisecond (msec) at the screening visit. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the participant's eligibility.
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 three units per day. Female participants who consume more than 14 units of alcohol per week or two units per day (one alcohol unit = one beer or one wine [5 ounces [oz]/150 milliliter [mL]] or one liquor [1.5 oz/40 mL] or 0.75 oz alcohol).
A positive screen for alcohol or drugs of abuse at the screening visit or on Day -1 of Treatment Period 1. Urine samples are to be tested for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine.
A positive Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen at the screening visit.
Use of tobacco in any form (example, smoking or chewing) or other nicotine-containing products in any form (example, gum, patch). Ex-users must self-report that they have stopped using tobacco for at least 3 months prior to receiving the first dose.
Routine consumption of more than two units of caffeine per day or participants who experience caffeine withdrawal headaches (One caffeine unit is contained in the following items: one 6-oz [180 mL] cup of coffee, two 12-oz [360 mL] cans of cola, one 12-oz cup of tea, three 1-oz [85 grams [g]] chocolate bars). Decaffeinated coffee, tea, or cola are not considered to contain caffeine.
Current use of any prescription medication with the exception of hormonal contraceptives and hormonal replacement therapy. Current use of any over-the-counter (OTC) medication (including OTC multi-vitamin, herbal, or homeopathic preparations) within 14 days of the first dose. Hormonal contraceptives and hormonal replacement therapy may be permitted if the female participant has been on the same stable dose for at least 3 months prior to first dose.
Current use of antacids, proton pump inhibitors (PPIs), or histamine type 2 (H2) antagonists within 14 days of the first dose, except for on-study rabeprazole.
Inability or unwillingness to consume 100 percent of the high-fat, high-calorie meal (including participants with lactose or gluten intolerance).
Female participants with a positive pregnancy test at the screening visit or on Day -1 of Treatment Period 1 or who are lactating.
Participants on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
Recent history (within 1 month) of oral/nasal cavity infections, history of gastroesophageal reflux, asthma treatment with albuterol, or zinc supplementation.
Participants with dry mouth syndrome or burning mouth syndrome or participants suffering from dysgeusia.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Participants to Evaluate the Relative Bioavailability of Maribavir Pediatric Formulation Compared to the Commercial Formulation, as Well as, Food Effect, and Rabeprazole Gastric Acid-Reducing Effect on the Pharmacokinetics of Single-Dose Maribavir Pediatric Formulation

The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part.

The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in the digestive tract compared to commercial tablet formulation and to check how a high-fat, high-calorie meal affects absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension.

The main aim of Part 2 of this study is to assess the stomach acid reducing effect of multiple doses of rabeprazole on absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension.

Each participant will stay in the study clinic from the day before the first treatment until the day after the last treatment.

Read the detailed description

Part 1 is a crossover design with three treatments (Treatments A, B, and C), six sequences, and three periods.

The relative bioavailability of 200 milligrams (mg) maribavir pediatric formulation administered orally as water suspension under fasting conditions (Treatment B) will be compared to 200 mg maribavir commercial tablet administered orally under fasting conditions (Treatment A). In addition, the effect of food on the pharmacokinetics (PK) of 200 mg maribavir pediatric formulation administered orally as water suspension under fasting conditions (Treatment B) and fed conditions (Treatment C) will be assessed. In each sequence, participants will receive three treatments (Treatments A, B, and C) per schedule.

Sequence 1: Treatment A + Treatment B + Treatment C
Sequence 2: Treatment A + Treatment C + Treatment B
Sequence 3: Treatment B + Treatment A + Treatment C
Sequence 4: Treatment B + Treatment C + Treatment A
Sequence 5: Treatment C + Treatment A + Treatment B
Sequence 6: Treatment C + Treatment B + Treatment A

Part 2 is a single fixed-sequence design with two treatments (Treatments D and E). The two treatments will be administered to evaluate the gastric acid-reducing effect of multiple doses of rabeprazole on the PK of a single dose of 200 mg maribavir pediatric formulation administered orally as water suspension.

Conditions: Healthy Volunteers
Being tested: Maribavir Commercial Tablet Formulation, Maribavir Pediatric Powder-for-oral Suspension Formulation, Rabeprazole

What participants receive

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

Maribavir Commercial Tablet FormulationDrug
Also called TAK-620
Maribavir commercial tablet.
Maribavir Pediatric Powder-for-oral Suspension FormulationDrug
Also called TAK-620
Maribavir pediatric powder-for-oral suspension.
RabeprazoleDrug
Rabeprazole tablet.

Study groups in NCT05918822
Study group	Role	What they receive
Part 1, Sequence 1: Treatment A + Treatment B + Treatment C	Experimental	Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment. Receives: Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 1, Sequence 2: Treatment A + Treatment C + Treatment B	Experimental	Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment. Receives: Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 1, Sequence 3: Treatment B + Treatment A + Treatment C	Experimental	Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment. Receives: Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 1, Sequence 4: Treatment B + Treatment C + Treatment A	Experimental	Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment. Receives: Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 1, Sequence 5: Treatment C + Treatment A + Treatment B	Experimental	Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment. Receives: Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A	Experimental	Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition as (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment. Receives: Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 2: Treatment D: maribavir 200 mg	Experimental	Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment D). Receives: Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation
Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg	Experimental	Participants will receive rabeprazole single 20 mg tablet, once daily on Days 1 to 5 of Treatment Period 2 under fasting condition followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose, 2 hours after rabeprazole dosing on morning of Day 5 of Treatment Period 2 under fasting condition (Treatment E). There will be a washout period of a minimum of 72 hours between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2. Receives: Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation; Drug: Rabeprazole

What is being measured

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

Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir
Cmax was defined as maximum observed concentration of maribavir in plasma.
Measured: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Maribavir
AUClast was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration of maribavir in plasma.
Measured: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir
AUC0-infinity was defined as the area under the plasma concentration-time curve from time 0 to infinity of maribavir in plasma.
Measured: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose

Secondary outcomes (3)

Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
A TEAE was defined as an adverse event (AE) that was starting or worsening at the time of or after the first dose of maribavir administered in the study. An serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was an important medical event that satisfies any of the following: might require intervention to prevent items 1 through 5 above and might exposed the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. Any clinically significant changes in vital signs, electrocardiogram (ECG) values and clinical laboratory parameters were considered as TEAEs.
Measured: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)
Number of Participants Based on Severity of TEAEs
Severity of TEAEs were determined by following criteria: Mild: An AE that was usually transient and might require only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living; Moderate: An AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but possessed no significant or permanent risk of harm to the research participant; Severe: An AE that interrupted usual activities of daily living, or significantly affects clinical status, or might require intensive therapeutic intervention.
Measured: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)
Number of Participants Based on Causality of TEAEs
The causality relationship of each AE to the study drug was assessed using the following categories: Related: An AE that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship was at least a reasonable possibility, that was, the relationship could not be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant drugs and concurrent treatments, might also be responsible; Not Related: An AE that did not follow a reasonable temporal sequence from administration of a drug and/or that could reasonably be explained by other factors, such as underlying diseases, complications, concomitant medications and concurrent treatments. Number of participants based on causality of TEAEs as assessed by the Investigator were reported.
Measured: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

Timeline

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

25 Jul 20231 Sep 2023

First posted26 Jun 2023
Study start25 Jul 2023
Primary completion25 Aug 2023
Study completion1 Sep 2023

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.
More trials run by TakedaThe sponsor's other registered studies.
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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05918822
Sponsor's protocol ID: TAK-620-1024
Status last verified: Jun 2024
First submitted: 16 Jun 2023
Last updated: 26 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Campagne O, Ilic K, Gabriel A, Sueda K, Ye R, Zhang F, Xu P, Ko HH, Sun K. A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Volunteers to Evaluate the Bioavailability of the Maribavir Powder for Oral Suspension, as Well as Food Effect and Impact of Rabeprazole. Clin Pharmacol Drug Dev. 2025 Feb;14(2):133-143. doi: 10.1002/cpdd.1493. Epub 2024 Dec 22.
PubMed 39711068

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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Participants to Evaluate the Relative Bioavailability of Maribavir Pediatric Formulation Compared to the Commercial Formulation, as Well as, Food Effect, and Rabeprazole Gastric Acid-Reducing Effect on the Pharmacokinetics of Single-Dose Maribavir Pediatric Formulation
ClinicalTrials.gov ID: NCT05918822
Acronym / sponsor ID: TAK-620-1024
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 25 Jul 2023 (actual)
Primary completion: 25 Aug 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 26 Jun 2023 (actual)
Results: Posted 26 Sep 2024

Clinical summary

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

The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part.

Each participant will stay in the study clinic from the day before the first treatment until the day after the last treatment.

Detailed description

Part 1 is a crossover design with three treatments (Treatments A, B, and C), six sequences, and three periods.

Sequence 1: Treatment A + Treatment B + Treatment C
Sequence 2: Treatment A + Treatment C + Treatment B
Sequence 3: Treatment B + Treatment A + Treatment C
Sequence 4: Treatment B + Treatment C + Treatment A
Sequence 5: Treatment C + Treatment A + Treatment B
Sequence 6: Treatment C + Treatment B + Treatment A

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Part 1, Sequence 1: Treatment A + Treatment B + Treatment C	Experimental	Drug: Maribavir Commercial Tablet Formulation, Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment.
Part 1, Sequence 2: Treatment A + Treatment C + Treatment B	Experimental	Drug: Maribavir Commercial Tablet Formulation, Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment.
Part 1, Sequence 3: Treatment B + Treatment A + Treatment C	Experimental	Drug: Maribavir Commercial Tablet Formulation, Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment.
Part 1, Sequence 4: Treatment B + Treatment C + Treatment A	Experimental	Drug: Maribavir Commercial Tablet Formulation, Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment.
Part 1, Sequence 5: Treatment C + Treatment A + Treatment B	Experimental	Drug: Maribavir Commercial Tablet Formulation, Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment.
Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A	Experimental	Drug: Maribavir Commercial Tablet Formulation, Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition as (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment.
Part 2: Treatment D: maribavir 200 mg	Experimental	Drug: Maribavir Pediatric Powder-for-oral Suspension FormulationParticipants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment D).
Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg	Experimental	Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation, Drug: RabeprazoleParticipants will receive rabeprazole single 20 mg tablet, once daily on Days 1 to 5 of Treatment Period 2 under fasting condition followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose, 2 hours after rabeprazole dosing on morning of Day 5 of Treatment Period 2 under fasting condition (Treatment E). There will be a washout period of a minimum of 72 hours between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2.

Who may qualify

Ages: 18 to 55 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 and to voluntarily sign (personally or via a legally authorized representative) informed consent form to participate in the study.
Age 18 to 55 years, inclusive at the time of consent, at the screening visit.
Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or female of non-childbearing potential.
Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2), inclusive with a body weight greater than (>) 50 kilograms (kg) (110 pounds [lbs]), at the screening visit.
Healthy as determined by the Investigator or designee on the basis of screening evaluations and medical history.

Key exclusion criteria (26 listed)

History or presence of gastritis, gastrointestinal (GI) tract disorder, hepatic disorder or cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in the opinion of the investigator or designee, may affect the absorption, distribution, metabolism, or elimination of the study drugs.
History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current recurrent disease that could affect the action, absorption, or disposition of the study drugs, or clinical or laboratory assessments.
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 study drugs or procedures.
Known or suspected intolerance or hypersensitivity to maribavir or rabeprazole (Part 2 only), closely related compounds, or any of the stated ingredients and excipients.
Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose of the investigational drug (ID).

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 Commercial Tablet FormulationAlso: TAK-620Maribavir commercial tablet.	Drug	Part 1, Sequence 1: Treatment A + Treatment B + Treatment C, Part 1, Sequence 2: Treatment A + Treatment C + Treatment B, Part 1, Sequence 3: Treatment B + Treatment A + Treatment C, Part 1, Sequence 4: Treatment B + Treatment C + Treatment A, Part 1, Sequence 5: Treatment C + Treatment A + Treatment B, Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A
Maribavir Pediatric Powder-for-oral Suspension FormulationAlso: TAK-620Maribavir pediatric powder-for-oral suspension.	Drug	Part 1, Sequence 1: Treatment A + Treatment B + Treatment C, Part 1, Sequence 2: Treatment A + Treatment C + Treatment B, Part 1, Sequence 3: Treatment B + Treatment A + Treatment C, Part 1, Sequence 4: Treatment B + Treatment C + Treatment A, Part 1, Sequence 5: Treatment C + Treatment A + Treatment B, Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A, Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg, Part 2: Treatment D: maribavir 200 mg
RabeprazoleRabeprazole tablet.	Drug	Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg

Primary outcome

Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir
Time frame: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose
Cmax was defined as maximum observed concentration of maribavir in plasma.
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Maribavir
Time frame: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose
AUClast was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration of maribavir in plasma.
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir
Time frame: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose
AUC0-infinity was defined as the area under the plasma concentration-time curve from time 0 to infinity of maribavir in plasma.

3 secondary outcomes

Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)
Number of Participants Based on Severity of TEAEs
Time frame: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)
Number of Participants Based on Causality of TEAEs
Time frame: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

Results and safety

Results posted to the registry on 26 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1, Sequence 1: Treatment A + Treatment B + Treatment C	3	3
Part 1, Sequence 2: Treatment A + Treatment C + Treatment B	3	3
Part 1, Sequence 3: Treatment B + Treatment A + Treatment C	3	3
Part 1, Sequence 4: Treatment B + Treatment C + Treatment A	3	3
Part 1, Sequence 5: Treatment C + Treatment A + Treatment B	3	3
Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A	3	3
Part 2: Treatment D + E: Maribavir 200 mg + Rabeprazole 20 mg	14	14

Primary outcome: Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir

Time frame: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: microgram per milliliter (mcg/mL)

Measure	Part 1, Treatment A: Maribavir 200 mg n = 18	Part 1, Treatment B: Maribavir 200 mg n = 18	Part 1, Treatment C: Maribavir 200 mg n = 18	Part 2, Treatment D: Maribavir 200 mg n = 14	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n = 14
Value	12.6 (26.3)	10.4 (26.2)	5.98 (28.3)	10.2 (19.9)	4.98 (49.9)

Part 1, Treatment A: Maribavir 200 mg vs Part 1, Treatment B: Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 82.19 (90% CI 74.31 to 90.91)
Part 1, Treatment B: Maribavir 200 mg vs Part 1, Treatment C: Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 57.72 (90% CI 52.18 to 63.84)
Part 2, Treatment D: Maribavir 200 mg vs Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 49.03 (90% CI 40.07 to 60.00)

Population analysed: Pharmacokinetic (PK) set included all participants who received at least one dose of maribavir, did not vomit or had diarrhea within four hours of the maribavir dosing, and had five or more post-dose time points with evaluable post-dose maribavir concentration values that enabled non-compartmental analysis (NCA).

Primary outcome: Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Maribavir

Measure	Part 1, Treatment A: Maribavir 200 mg n = 18	Part 1, Treatment B: Maribavir 200 mg n = 18	Part 1, Treatment C: Maribavir 200 mg n = 18	Part 2, Treatment D: Maribavir 200 mg n = 14	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n = 14
Value	55.5 (52.6)	54.2 (50.2)	44.4 (51.9)	53.9 (37.3)	37.7 (36.8)

Part 1, Treatment A: Maribavir 200 mg vs Part 1, Treatment B: Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 97.59 (90% CI 91.39 to 104.20)
Part 1, Treatment B: Maribavir 200 mg vs Part 1, Treatment C: Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 82.05 (90% CI 76.84 to 87.61)
Part 2, Treatment D: Maribavir 200 mg vs Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 70.00 (90% CI 60.11 to 81.51)

Population analysed: PK set included all participants who received at least one dose of maribavir, did not vomit or had diarrhea within four hours of the maribavir dosing, and had five or more post-dose time points with evaluable post-dose maribavir concentration values that enabled NCA.

Primary outcome: Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir

Measure	Part 1, Treatment A: Maribavir 200 mg n = 18	Part 1, Treatment B: Maribavir 200 mg n = 18	Part 1, Treatment C: Maribavir 200 mg n = 18	Part 2, Treatment D: Maribavir 200 mg n = 14	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n = 10
Value	59.1 (55.9)	59.1 (56.3)	48.2 (57.6)	57.2 (38.5)	50.1 (35.4)

Part 1, Treatment A: Maribavir 200 mg vs Part 1, Treatment B: Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 99.94 (90% CI 94.12 to 106.11)
Part 1, Treatment B: Maribavir 200 mg vs Part 1, Treatment C: Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 81.68 (90% CI 76.93 to 86.73)
Part 2, Treatment D: Maribavir 200 mg vs Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg: Geometric Mean Ratio (GMR) (%): 88.92 (90% CI 76.94 to 102.78)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1, Treatment A: Maribavir 200 mg	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Part 1, Treatment B: Maribavir 200 mg	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Part 1, Treatment C: Maribavir 200 mg	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Part 2, Treatment D: Maribavir 200 mg	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Part 2, Treatment E1: Rabeprazole 20 mg	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Part 2, Treatment E2: Maribavir 200 mg	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39711068Campagne O, Ilic K, Gabriel A, Sueda K, Ye R, Zhang F, Xu P, Ko HH, Sun K. A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Volunteers to Evaluate the Bioavailability of the Maribavir Powder for Oral Suspension, as Well as Food Effect and Impact of Rabeprazole. Clin Pharmacol Drug Dev. 2025 Feb;14(2):133-143. doi: 10.1002/cpdd.1493. Epub 2024 Dec 22.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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

Takeda

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

Questions about this trial

What is this clinical trial studying?

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 26 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 26 Sep 2024. 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 26 Sep 2024). 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?

Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir (time frame: Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 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 NCT05918822, 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 26 Sep 2024.