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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maribavir Commercial Tablet Formulation | Drug | Maribavir commercial tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir | Cmax was defined as maximum observed concentration of maribavir in plasma. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39711068 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 32 participants were enrolled and randomized in this 2-part (18 in Part 1 and 14 in Part 2) study. Part 1 consisted of 3 treatment-periods and participants were randomized into one of 6 treatment sequences: ABC, ACB, BAC, BCA, CAB, or CBA. Part 2 consisted of 2-treatment periods and was a single fixed-sequence design with 2 treatments: Treatment D and E.
This study was conducted at single center in the United States from 25 July 2023 to 01 September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1, Sequence 1: Treatment A + Treatment B + Treatment C | On Day 1 of Treatment Period 1, participants received maribavir single 200 milligrams (mg) commercial tablet, under fasting conditions (Treatment A). On Day 1 of Treatment Period 2, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal (Treatment C). There was a washout period of a minimum of 3 days between each Treatment Period. |
| FG001 | Part 1, Sequence 2: Treatment A + Treatment C + Treatment B | On Day 1 of Treatment Period 1, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A), followed by single oral dose of maribavir 200 mg pediatric powder-for-oral suspension on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by single oral dose of maribavir 200 mg pediatric powder-for-oral suspension on Day 1 of Treatment Period 3 under fasting conditions (Treatment B). There was a washout period of a minimum of 3 days between each Treatment Period. |
| FG002 | Part 1, Sequence 3: Treatment B + Treatment A + Treatment C | On Day 1 of Treatment Period 1, participants received a single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 2, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). On Day 1 of Treatment Period 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal (Treatment C). There was a washout period of a minimum of 3 days between each Treatment Period. |
| FG003 | Part 1, Sequence 4: Treatment B + Treatment C + Treatment A | On Day 1 of Treatment Period 1, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 2 participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal (Treatment C). On Day 1 of Treatment Period 3, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). There was a washout period of a minimum of 3 days between each Treatment Period. |
| FG004 | Part 1, Sequence 5: Treatment C + Treatment A + Treatment B | On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension, single oral dose administered with a high fat/high calorie meal (Treatment C). On Day 1 of Treatment Period 2, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). On Day 1 of Treatment Period 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). There was a washout period of a minimum of 3 days between each Treatment Period. |
| FG005 | Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A | On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension, single oral dose administered with a high fat/high calorie meal (Treatment C). On Day 1 of Treatment Period 2, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 3, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). There was a washout period of a minimum of 3 days between each Treatment Period. |
| FG006 | Part 2: Treatment D + E: Maribavir 200 mg + Rabeprazole 20 mg | On Day 1 of Treatment Period 1, participants received a single oral dose of 200 mg maribavir powder-for-oral suspension formulation under fasting conditions (Treatment D). On Days 1 to 5 of Treatment Period 2, participants received oral doses of 20 mg rabeprazole, once daily, under fasting conditions. On the morning of Day 5 of Treatment Period 2, two hours after rabeprazole dosing, participants received a single oral dose of 200 mg maribavir powder-for-oral suspension formulation under fasting conditions (Treatment E). There was a washout period of a minimum of 3 days between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Part 1 and 2: 1 Day) |
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| Washout Period 1 (Part 1 and 2: 3 Days) |
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| Treatment Period2Part1:1Day;Part2:Day1-5 |
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| Washout Period 2 (Part 1 Only: 3 Days) |
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| Treatment Period 3 (Part 1 Only: 1 Day) |
|
Safety set included all participants who received at least one dose of maribavir.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, Sequence 1: Treatment A + Treatment B + Treatment C | On Day 1 of Treatment Period 1, participants received maribavir single 200 milligrams (mg) commercial tablet, under fasting conditions (Treatment A). On Day 1 of Treatment Period 2, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal (Treatment C). There was a washout period of a minimum of 3 days between each Treatment Period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir | Cmax was defined as maximum observed concentration of maribavir in plasma. | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | 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 |
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Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)
Safety set included all participants who received at least one dose of maribavir.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1, Treatment A: Maribavir 200 mg | On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir single 200 mg commercial tablet under fasting conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2023 | Jun 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2023 | Jun 4, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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. |
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| 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. |
|
| 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. |
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| 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). |
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| 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. |
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| Maribavir Pediatric Powder-for-oral Suspension Formulation | Drug | Maribavir pediatric powder-for-oral suspension. |
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| Rabeprazole | Drug | Rabeprazole tablet. |
|
| 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. | 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. | Parts 1 and 2: From start of study drug administration up to follow-up (Day 16) |
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| BG001 | Part 1, Sequence 2: Treatment A + Treatment C + Treatment B | On Day 1 of Treatment Period 1, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A), followed by single oral dose of maribavir 200 mg pediatric powder-for-oral suspension on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by single oral dose of maribavir 200 mg pediatric powder-for-oral suspension on Day 1 of Treatment Period 3 under fasting conditions (Treatment B). There was a washout period of a minimum of 3 days between each Treatment Period. |
| BG002 | Part 1, Sequence 3: Treatment B + Treatment A + Treatment C | On Day 1 of Treatment Period 1, participants received a single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 2, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). On Day 1 of Treatment Period 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal (Treatment C). There was a washout period of a minimum of 3 days between each Treatment Period. |
| BG003 | Part 1, Sequence 4: Treatment B + Treatment C + Treatment A | On Day 1 of Treatment Period 1, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 2 participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal (Treatment C). On Day 1 of Treatment Period 3, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). There was a washout period of a minimum of 3 days between each Treatment Period. |
| BG004 | Part 1, Sequence 5: Treatment C + Treatment A + Treatment B | On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension, single oral dose administered with a high fat/high calorie meal (Treatment C). On Day 1 of Treatment Period 2, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). On Day 1 of Treatment Period 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). There was a washout period of a minimum of 3 days between each Treatment Period. |
| BG005 | Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A | On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension, single oral dose administered with a high fat/high calorie meal (Treatment C). On Day 1 of Treatment Period 2, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions (Treatment B). On Day 1 of Treatment Period 3, participants received maribavir single 200 mg commercial tablet under fasting conditions (Treatment A). There was a washout period of a minimum of 3 days between each Treatment Period. |
| BG006 | Part 2: Treatment D + E: Maribavir 200 mg + Rabeprazole 20 mg | On Day 1 of Treatment Period 1, participants received a single oral dose of 200 mg maribavir powder-for-oral suspension formulation under fasting conditions (Treatment D). On Days 1 to 5 of Treatment Period 2, participants received oral doses of 20 mg rabeprazole, once daily, under fasting conditions. On the morning of Day 5 of Treatment Period 2, two hours after rabeprazole dosing, participants received a single oral dose of 200 mg maribavir powder-for-oral suspension formulation under fasting conditions (Treatment E). There was a washout period of a minimum of 3 days between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2. |
| BG007 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Part 1, Treatment B: Maribavir 200 mg | On Day 1 of Treatment Period 1, 2 and 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions. |
| OG002 | Part 1, Treatment C: Maribavir 200 mg | On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal. |
| OG003 | Part 2, Treatment D: Maribavir 200 mg | On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions. |
| OG004 | Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg | On Days 1 to 5 of Treatment Period 2, participants received oral doses of 20 mg rabeprazole, once daily, under fasting conditions. On the morning of Day 5 of Treatment Period 2, two hours after rabeprazole dosing, participants received a single oral dose of 200 mg maribavir powder-for-oral suspension formulation under fasting conditions. |
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| Primary | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter (mcg*h/mL) | 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 |
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| Primary | 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. | 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. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*h/mL | 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 |
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| Secondary | 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. | Safety set included all participants who received at least one dose of maribavir. | Posted | Count of Participants | Participants | Parts 1 and 2: From start of study drug administration up to follow-up (Day 16) |
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| Secondary | 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. | Safety set included all participants who received at least one dose of maribavir. | Posted | Count of Participants | Participants | Parts 1 and 2: From start of study drug administration up to follow-up (Day 16) |
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| Secondary | 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. | Safety set included all participants who received at least one dose of maribavir. | Posted | Count of Participants | Participants | Parts 1 and 2: From start of study drug administration up to follow-up (Day 16) |
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|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | Part 1, Treatment B: Maribavir 200 mg | On Day 1 of Treatment Period 1, 2 and 3, participants received single oral dose of maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Part 1, Treatment C: Maribavir 200 mg | On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir 200 mg pediatric powder-for-oral suspension administered with a high fat/high calorie meal. | 0 | 18 | 0 | 18 | 2 | 18 |
| EG003 | Part 2, Treatment D: Maribavir 200 mg | On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG004 | Part 2, Treatment E1: Rabeprazole 20 mg | On Days 1 to 5 of Treatment Period 2, participants received oral doses of 20 mg rabeprazole, once daily, under fasting conditions. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG005 | Part 2, Treatment E2: Maribavir 200 mg | On the morning of Day 5 of Treatment Period 2, two hours after rabeprazole dosing, participants received a single oral dose of 200 mg maribavir powder-for-oral suspension formulation under fasting conditions. | 0 | 14 | 0 | 14 | 1 | 14 |
| Dysuria | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
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| Facial pain | General disorders | MedDRA 26 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
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Not provided
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Comparison of AUClast of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference) | Geometric Mean Ratio (GMR) (%) | 82.05 | 2-Sided | 90 | 76.84 | 87.61 | GMR (%) was calculated as 100*(Test/Reference). | Other | A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B. |
| Comparison of AUClast of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference) | Geometric Mean Ratio (GMR) (%) | 70.00 | 2-Sided | 90 | 60.11 | 81.51 | GMR (%) was calculated as 100*(Test/Reference). | Other | A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D. |
| Comparison of AUC0-infinity of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference) | Geometric Mean Ratio (GMR) (%) | 81.68 | 2-Sided | 90 | 76.93 | 86.73 | Other | A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B. |
| Comparison of AUC0-infinity of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference) | Geometric Mean Ratio (GMR) (%) | 88.92 | 2-Sided | 90 | 76.94 | 102.78 | GMR (%) was calculated as 100*(Test/Reference). | Other | A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D. |
| Serious TEAEs |
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| Moderate |
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| Severe |
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| Not Related TEAEs |
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