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

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04497883
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Maribavir (400 mg); Drug: Maribavir (200 mg); Drug: Maribavir (800 mg)	Phase 1

Detailed Description

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Subjects Compared With Matched, Healthy, Non-Hispanic, Caucasian Subjects and to Assess Dose-Proportionality of 3 Doses of Maribavir in the Japanese Subjects
• Actual Study Start Date: Aug 7, 2020
• Actual Primary Completion Date: Nov 12, 2020
• Actual Study Completion Date: Nov 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A: Non-Hispanic, Caucasian Non-Hispanic, Caucasian group participants will receive 400 milligram (mg) maribavir tablets orally once on Day 1 during treatment period 1.	Drug: Maribavir (400 mg); Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.; Other Names: SHP620 TAK-620
Experimental: Cohort B: Japanese Descent Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1 followed by 200 mg or 800 mg maribavir tablets orally once on Day 1 during treatment period 2 followed by 800 mg or 200 mg maribavir tablets orally once on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours will be maintained between treatment period 1, 2, and 3.	Drug: Maribavir (400 mg); Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.; Other Names: SHP620 TAK-620 ; Drug: Maribavir (200 mg); Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.; Other Names: SHP620 TAK-620 ; Drug: Maribavir (800 mg); Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.; Other Names: SHP620 TAK-620

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of Maribavir [Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose]

   Cmax of maribavir in plasma were reported.

2. Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir [Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose]

   AUClast of maribavir in plasma were reported.

3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir [Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose]

   AUC(0-infinity) of maribavir in plasma were reported.

Secondary Outcome Measures

1. Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants [Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose]

   Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.

2. Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants [Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose]

   Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.

3. Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants [Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose]

   Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.

4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [From start of study drug administration to follow-up (up to Day 23)]

   An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• An understanding, ability, and willingness to fully comply with study procedures and restrictions.

• Ability to voluntarily provide written informed consent/assent as applicable to participate in the study.

• Healthy 18 to 55 years old participants of Japanese descent and non-Hispanic Caucasian origin.

• Healthy participants of Japanese descent must have been born in Japan and must not have lived outside of Japan for greater than (>) 10 years; both parents and all 4 grandparents must be of Japanese origin. Healthy, non-Hispanic, Caucasian participants must have both parents and all 4 grandparents of non-Hispanic, Caucasian origin.

• Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

• Hemoglobin for males greater than or equal to (>=) 135.0 gram per liter (g/L) and females >= 120.0 g/L at screening and on Day -1.

• Body mass index (BMI) between 18.5 and 28.0 kilogram per square meter (kg/m^2) inclusive with a body weight > 45 kilograms (kg) (99 pounds [lbs]).

• Ability to swallow a dose of investigational product (IP).

Exclusion Criteria:

• History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current recurrent disease.

• Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.

• Known or suspected intolerance or hypersensitivity to maribavir, closely-related compounds, or any of the stated ingredients.

• Significant illness, as judged by the investigator, within 2 weeks of the first dose of IP.

• Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the first dose of IP.

• Have taken another IP within 30 days or five half-lives of that IP, whichever is greater, prior to the first dose of maribavir.

• Have been enrolled in a clinical study (including vaccine studies) within 30 days prior to the first dose of IP that, in the investigator's opinion, may impact this study.

• Have had any substantial changes in eating habits within 30 days prior to the first dose of IP, as assessed by the investigator.

• Confirmed systolic blood pressure > 139 millimeter of mercury (mmHg) or less than (<) 89 mmHg, and diastolic blood pressure > 89 mmHg or < 49 mmHg.

• Twelve-lead ECG demonstrating QTc > 450 milliseconds (msec).

• Known history of alcohol or other substance abuse, including synthetic cannabinoids within the last year.

• Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.

• A positive urine test for drugs of abuse, alcohol, or cotinine at screening or on Day -1.

• A positive human immunodeficiency virus (HIV), hepatitis B surface antibody (HBsAg), or hepatitis C virus (HCV) antibody screen.

• Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch).

• Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches.

• Current use of any prescription medication within 30 days of the first dose of IP. Current use of any over the counter medication within 14 days of the first dose of IP.

• Ingestion of known cytochrome P450 (CYP) 3A modulators within 7 days of Day 1, period 1

• History of active or chronic oral/nasal cavity infections, gastroesophageal reflux, asthma treatment with albuterol, zinc supplementation.

• Participants with dry mouth syndrome or burning mouth syndrome or menopausal women suffering from dysgeusia.

• Participants who have acute gastrointestinal (GI) symptoms at screening or admission (e.g. nausea, vomiting, diarrhea, and heartburn).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Las Vegas	Nevada	United States	89113

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Shire

Study Documents (Full-Text)

• Study Protocol - Jul 8, 2020
• Statistical Analysis Plan - Aug 6, 2020

More Information

Additional Information:

• To obtain more information on the study, click here/on this link

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT04497883
• Other Study ID Numbers: TAK-620-1020
• First Posted: Aug 4, 2020
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Maribavir

Study Results

Participant Flow

Recruitment Details	This study was conducted at single center in the United States from 07 Aug 2020 (first participant first visit) to 12 Nov 2020 (last participant last visit).
Pre-assignment Detail	A total of 24 participants (12 non-Hispanic Caucasian participants in Cohort A and 12 Japanese participants in Cohort B) were enrolled, randomized and received the study treatment in this study.

Arm/Group Title	Cohort A: Non-Hispanic, Caucasian	Cohort B: Japanese Descent: Maribavir 400mg	Cohort B: Japanese Descent: First Maribavir 200 mg Then Maribavir 800 mg	Cohort B: Japanese Descent: First Maribavir 800 mg Then Maribavir 200 mg
Arm/Group Description	Non-Hispanic, Caucasian participants received single dose of 400 milligram (mg) maribavir tablets orally on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants who received 400 mg maribavir tablets during treatment period 1 received single dose of 200 mg maribavir tablet orally on Day 1 during treatment period 2 followed by single dose of 800 mg maribavir tablets orally on Day 1 during treatment period 3. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.	Japanese descent participants who received 400 mg maribavir tablets during treatment period 1 received single dose of 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 200 mg maribavir tablet orally on Day 1 during treatment period 3. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
Period Title: Treatment Period 1 (2 Days)
STARTED	12	12	0	0
COMPLETED	12	12	0	0
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (2 Days)
STARTED	12	12	0	0
COMPLETED	12	12	0	0
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (2 Days)
STARTED	0	0	6	6
COMPLETED	0	0	6	6
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (2 Days)
STARTED	0	0	6	6
COMPLETED	0	0	6	6
NOT COMPLETED	0	0	0	0
Period Title: Treatment Period 1 (2 Days)
STARTED	0	0	6	6
COMPLETED	0	0	6	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort A: Non-Hispanic, Caucasian	Cohort B: Japanese Descent	Total
Arm/Group Description	Non-Hispanic, Caucasian participants received 400 mg maribavir tablets orally once on Day 1 during treatment period 1.	Japanese descent participants received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.	Total of all reporting groups
Overall Participants	12	12	24
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.3 (9.33)	40.8 (8.92)	40.0 (8.95)
Sex: Female, Male (Count of Participants)
Female	2 16.7%	2 16.7%	4 16.7%
Male	10 83.3%	10 83.3%	20 83.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 100%	12 100%	24 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	12 100%	12 50%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	12 100%	0 0%	12 50%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Maribavir
Description	Cmax of maribavir in plasma were reported.
Time Frame	Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cohort A: Maribavir 400 mg	Cohort B: Maribavir 400 mg	Cohort B: Maribavir 200 mg	Cohort B: Maribavir 800 mg
Arm/Group Description	Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.	Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
Measure Participants	12	12	12	12
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter (mcg/mL)]	15.8 (26.6)	17.4 (27.4)	9.03 (34.0)	26.3 (30.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A: Maribavir 400 mg, Cohort B: Maribavir 400 mg
	Comments	The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.
	Type of Statistical Test	Equivalence
	Comments	Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	% Ratio of Geometric least square means
	Estimated Value	110.41
	Confidence Interval	(2-Sided) 90%; 91.70 to 132.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
Description	AUClast of maribavir in plasma were reported.
Time Frame	Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cohort A: Maribavir 400 mg	Cohort B: Maribavir 400 mg	Cohort B: Maribavir 200 mg	Cohort B: Maribavir 800 mg
Arm/Group Description	Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.	Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
Measure Participants	12	12	12	12
Geometric Mean (Geometric Coefficient of Variation) [Hour*microgram per milliliter (h*mcg/mL)]	75.3 (33.6)	92.3 (35.3)	41.3 (40.8)	183 (40.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A: Maribavir 400 mg, Cohort B: Maribavir 400 mg
	Comments	The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.
	Type of Statistical Test	Equivalence
	Comments	Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	% Ratio of Geometric least square means
	Estimated Value	122.49
	Confidence Interval	(2-Sided) 90%; 96.83 to 154.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cohort A: Maribavir 400 mg	Cohort B: Maribavir 400 mg	Cohort B: Maribavir 200 mg	Cohort B: Maribavir 800 mg
Arm/Group Description	Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.	Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
Measure Participants	12	12	12	12
Geometric Mean (Geometric Coefficient of Variation) [h*mcg/mL]	77.3 (34.7)	96.7 (37.1)	43.0 (42.4)	195 (43.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cohort A: Maribavir 400 mg, Cohort B: Maribavir 400 mg
	Comments	The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.
	Type of Statistical Test	Equivalence
	Comments	Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	% Ratio of Geometric least square means
	Estimated Value	125.08
	Confidence Interval	(2-Sided) 90%; 97.99 to 159.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants
Description	Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.
Time Frame	Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of Cmax of maribavir was planned to be evaluated in Japanese descent participants only.

Arm/Group Title	Cohort B: Japanese Descent
Arm/Group Description	All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
Measure Participants	12
Number (90% Confidence Interval) [ln (Cmax [mcg/mL])]	0.771

5. Secondary Outcome

Title	Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants
Description	Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.
Time Frame	Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of AUClast of maribavir was planned to be evaluated in Japanese descent participants only.

Arm/Group Title	Cohort B: Japanese Descent
Arm/Group Description	All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
Measure Participants	12
Number (90% Confidence Interval) [ln (AUClast[h*mcg/mL])]	1.07

6. Secondary Outcome

Title	Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants
Description	Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.
Time Frame	Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of AUC0-infinity of maribavir was planned to be evaluated in Japanese descent participants only.

Arm/Group Title	Cohort B: Japanese Descent
Arm/Group Description	All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.
Measure Participants	12
Number (90% Confidence Interval) [ln (AUC0-infnity[h*mcg/mL])]	1.09

7. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Description	An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.
Time Frame	From start of study drug administration to follow-up (up to Day 23)

Outcome Measure Data

Analysis Population Description

The safety set consisted of participants who were administered at least 1 dose of maribavir and had at least 1 post-dose safety assessment.

Arm/Group Title	Cohort A: Maribavir 400 mg	Cohort B: Maribavir 400 mg	Cohort B: Maribavir 200 mg	Cohort B: Maribavir 800 mg
Arm/Group Description	Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.	Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.	Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
Measure Participants	12	12	12	12
Participants with TEAEs	4 33.3%	2 16.7%	1 4.2%	0 NaN
Participants with serious TEAEs	0 0%	0 0%	0 0%	0 NaN

Adverse Events

Time Frame	From start of study drug administration to follow-up (up to Day 23)
Arm/Group Title	Cohort A: Maribavir 400 mg		Cohort B: Maribavir 400 mg		Cohort B: Maribavir 200 mg		Cohort B: Maribavir 800 mg
Arm/Group Description	Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.		Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.		Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.		Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
All Cause Mortality
	Cohort A: Maribavir 400 mg		Cohort B: Maribavir 400 mg		Cohort B: Maribavir 200 mg		Cohort B: Maribavir 800 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Cohort A: Maribavir 400 mg		Cohort B: Maribavir 400 mg		Cohort B: Maribavir 200 mg		Cohort B: Maribavir 800 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Cohort A: Maribavir 400 mg		Cohort B: Maribavir 400 mg		Cohort B: Maribavir 200 mg		Cohort B: Maribavir 800 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/12 (33.3%)		2/12 (16.7%)		1/12 (8.3%)		0/12 (0%)
Nervous system disorders
Dysgeusia	4/12 (33.3%)	4	2/12 (16.7%)	2	1/12 (8.3%)	1	0/12 (0%)	0
Somnolence	2/12 (16.7%)	2	0/12 (0%)	0	0/12 (0%)	0	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.