Trial Outcomes & Findings for A Study of Maribavir Pediatric Formulation in Healthy Adult Participants (NCT NCT05918822)

NCT ID: NCT05918822

Last Updated: 2024-09-26

Results Overview

Cmax was defined as maximum observed concentration of maribavir in plasma.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

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

Results posted on

2024-09-26

Participant Flow

This study was conducted at single center in the United States from 25 July 2023 to 01 September 2023.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.	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.
Treatment Period 1 (Part 1 and 2: 1 Day) STARTED	3	3	3	3	3	3	14
Treatment Period 1 (Part 1 and 2: 1 Day) COMPLETED	3	3	3	3	3	3	14
Treatment Period 1 (Part 1 and 2: 1 Day) NOT COMPLETED	0	0	0	0	0	0	0
Washout Period 1 (Part 1 and 2: 3 Days) STARTED	3	3	3	3	3	3	14
Washout Period 1 (Part 1 and 2: 3 Days) COMPLETED	3	3	3	3	3	3	14
Washout Period 1 (Part 1 and 2: 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Treatment Period2Part1:1Day;Part2:Day1-5 STARTED	3	3	3	3	3	3	14
Treatment Period2Part1:1Day;Part2:Day1-5 COMPLETED	3	3	3	3	3	3	14
Treatment Period2Part1:1Day;Part2:Day1-5 NOT COMPLETED	0	0	0	0	0	0	0
Washout Period 2 (Part 1 Only: 3 Days) STARTED	3	3	3	3	3	3	0
Washout Period 2 (Part 1 Only: 3 Days) COMPLETED	3	3	3	3	3	3	0
Washout Period 2 (Part 1 Only: 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Treatment Period 3 (Part 1 Only: 1 Day) STARTED	3	3	3	3	3	3	0
Treatment Period 3 (Part 1 Only: 1 Day) COMPLETED	3	3	3	3	3	3	0
Treatment Period 3 (Part 1 Only: 1 Day) NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Maribavir Pediatric Formulation in Healthy Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, Sequence 1: Treatment A + Treatment B + Treatment C n=3 Participants 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.	Part 1, Sequence 2: Treatment A + Treatment C + Treatment B n=3 Participants 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.	Part 1, Sequence 3: Treatment B + Treatment A + Treatment C n=3 Participants 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.	Part 1, Sequence 4: Treatment B + Treatment C + Treatment A n=3 Participants 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.	Part 1, Sequence 5: Treatment C + Treatment A + Treatment B n=3 Participants 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.	Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A n=3 Participants 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.	Part 2: Treatment D + E: Maribavir 200 mg + Rabeprazole 20 mg n=14 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	14 Participants n=115 Participants	32 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	6 Participants n=115 Participants	15 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	8 Participants n=115 Participants	17 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants	21 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	11 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants	8 Participants n=6 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	10 Participants n=115 Participants	23 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: 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

Population: 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).

Cmax was defined as maximum observed concentration of maribavir in plasma.

Outcome measures

Outcome measures
Measure	Part 1, Treatment A: Maribavir 200 mg n=18 Participants On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir single 200 mg commercial tablet under fasting conditions.	Part 1, Treatment B: Maribavir 200 mg n=18 Participants 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.	Part 1, Treatment C: Maribavir 200 mg n=18 Participants 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.	Part 2, Treatment D: Maribavir 200 mg n=14 Participants On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions.	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n=14 Participants 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.	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.
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir	12.6 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 26.3	10.4 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 26.2	5.98 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 28.3	10.2 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 19.9	4.98 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 49.9	—

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Part 1, Treatment A: Maribavir 200 mg n=18 Participants On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir single 200 mg commercial tablet under fasting conditions.	Part 1, Treatment B: Maribavir 200 mg n=18 Participants 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.	Part 1, Treatment C: Maribavir 200 mg n=18 Participants 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.	Part 2, Treatment D: Maribavir 200 mg n=14 Participants On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions.	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n=14 Participants 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.	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.
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	55.5 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 52.6	54.2 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 50.2	44.4 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 51.9	53.9 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 37.3	37.7 microgramhour per milliliter (mcgh/mL) Geometric Coefficient of Variation 36.8	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part 1, Treatment A: Maribavir 200 mg n=18 Participants On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir single 200 mg commercial tablet under fasting conditions.	Part 1, Treatment B: Maribavir 200 mg n=18 Participants 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.	Part 1, Treatment C: Maribavir 200 mg n=18 Participants 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.	Part 2, Treatment D: Maribavir 200 mg n=14 Participants On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions.	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n=10 Participants 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.	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.
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir	59.1 mcg*h/mL Geometric Coefficient of Variation 55.9	59.1 mcg*h/mL Geometric Coefficient of Variation 56.3	48.2 mcg*h/mL Geometric Coefficient of Variation 57.6	57.2 mcg*h/mL Geometric Coefficient of Variation 38.5	50.1 mcg*h/mL Geometric Coefficient of Variation 35.4	—

SECONDARY outcome

Timeframe: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

Population: Safety set included all participants who received at least one dose of maribavir.

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.

Outcome measures

Outcome measures
Measure	Part 1, Treatment A: Maribavir 200 mg n=18 Participants On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir single 200 mg commercial tablet under fasting conditions.	Part 1, Treatment B: Maribavir 200 mg n=18 Participants 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.	Part 1, Treatment C: Maribavir 200 mg n=18 Participants 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.	Part 2, Treatment D: Maribavir 200 mg n=14 Participants On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions.	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n=14 Participants 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.	Part 2, Treatment E2: Maribavir 200 mg n=14 Participants 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.
Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

Population: Safety set included all participants who received at least one dose of maribavir.

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.

Outcome measures

Outcome measures
Measure	Part 1, Treatment A: Maribavir 200 mg n=18 Participants On Day 1 of Treatment Period 1, 2 and 3, participants received maribavir single 200 mg commercial tablet under fasting conditions.	Part 1, Treatment B: Maribavir 200 mg n=18 Participants 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.	Part 1, Treatment C: Maribavir 200 mg n=18 Participants 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.	Part 2, Treatment D: Maribavir 200 mg n=14 Participants On Day 1 of Treatment Period 1, participants received maribavir 200 mg pediatric powder-for-oral suspension under fasting conditions.	Part 2, Treatment E: Rabeprazole 20 mg + Maribavir 200 mg n=14 Participants 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.	Part 2, Treatment E2: Maribavir 200 mg n=14 Participants 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.
Number of Participants Based on Severity of TEAEs Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Based on Severity of TEAEs Mild	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Based on Severity of TEAEs Moderate	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

Population: Safety set included all participants who received at least one dose of maribavir.

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.