Trial Outcomes & Findings for 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 (NCT NCT04497883)
NCT ID: NCT04497883
Last Updated: 2025-09-11
Results Overview
Cmax of maribavir in plasma were reported.
COMPLETED
PHASE1
24 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
2025-09-11
Participant Flow
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).
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.
Participant milestones
| Measure |
Cohort A: Non-Hispanic, Caucasian
Non-Hispanic, Caucasian participants received single dose of 400 milligram (mg) maribavir tablets orally on Day 1 during treatment period 1.
|
Cohort B: Japanese Descent: Maribavir 400mg
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Japanese Descent: First Maribavir 200 mg Then Maribavir 800 mg
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.
|
Cohort B: Japanese Descent: First Maribavir 800 mg Then Maribavir 200 mg
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.
|
|---|---|---|---|---|
|
Treatment Period 1 (2 Days)
STARTED
|
12
|
12
|
0
|
0
|
|
Treatment Period 1 (2 Days)
COMPLETED
|
12
|
12
|
0
|
0
|
|
Treatment Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (72 Hours)
STARTED
|
12
|
12
|
0
|
0
|
|
Washout Period 1 (72 Hours)
COMPLETED
|
12
|
12
|
0
|
0
|
|
Washout Period 1 (72 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (2 Days)
STARTED
|
0
|
0
|
6
|
6
|
|
Treatment Period 2 (2 Days)
COMPLETED
|
0
|
0
|
6
|
6
|
|
Treatment Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (72 Hours)
STARTED
|
0
|
0
|
6
|
6
|
|
Washout Period 2 (72 Hours)
COMPLETED
|
0
|
0
|
6
|
6
|
|
Washout Period 2 (72 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (2 Days)
STARTED
|
0
|
0
|
6
|
6
|
|
Treatment Period 3 (2 Days)
COMPLETED
|
0
|
0
|
6
|
6
|
|
Treatment Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Cohort A: Non-Hispanic, Caucasian
n=12 Participants
Non-Hispanic, Caucasian participants received 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
|
Cohort B: Japanese Descent
n=12 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 Years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
40.8 Years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
40.0 Years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The pharmacokinetic (PK) set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.
Cmax of maribavir in plasma were reported.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
n=12 Participants
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
n=12 Participants
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
n=12 Participants
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Maribavir
|
15.8 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26.6
|
17.4 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 27.4
|
9.03 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 34.0
|
26.3 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 30.7
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.
AUClast of maribavir in plasma were reported.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
n=12 Participants
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
n=12 Participants
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
n=12 Participants
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
|
75.3 Hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 33.6
|
92.3 Hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 35.3
|
41.3 Hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 40.8
|
183 Hour*microgram per milliliter (h*mcg/mL)
Geometric Coefficient of Variation 40.6
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.
AUC(0-infinity) of maribavir in plasma were reported.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
n=12 Participants
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
n=12 Participants
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
n=12 Participants
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir
|
77.3 h*mcg/mL
Geometric Coefficient of Variation 34.7
|
96.7 h*mcg/mL
Geometric Coefficient of Variation 37.1
|
43.0 h*mcg/mL
Geometric Coefficient of Variation 42.4
|
195 h*mcg/mL
Geometric Coefficient of Variation 43.9
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants
|
0.771 ln (Cmax [mcg/mL])
Interval 0.62 to 0.92
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants
|
1.07 ln (AUClast[h*mcg/mL])
Interval 0.89 to 1.26
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants
|
1.09 ln (AUC0-infnity[h*mcg/mL])
Interval 0.9 to 1.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration to follow-up (up to Day 23)Population: The safety set consisted of participants who were administered at least 1 dose of maribavir and had at least 1 post-dose safety assessment.
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.
Outcome measures
| Measure |
Cohort A: Maribavir 400 mg
n=12 Participants
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
n=12 Participants
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
n=12 Participants
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
n=12 Participants
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort A: Maribavir 400 mg
Cohort B: Maribavir 400 mg
Cohort B: Maribavir 200 mg
Cohort B: Maribavir 800 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: Maribavir 400 mg
n=12 participants at risk
Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 400 mg
n=12 participants at risk
Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.
|
Cohort B: Maribavir 200 mg
n=12 participants at risk
Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
Cohort B: Maribavir 800 mg
n=12 participants at risk
Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.
|
|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
33.3%
4/12 • Number of events 4 • From start of study drug administration to follow-up (up to Day 23)
|
16.7%
2/12 • Number of events 2 • From start of study drug administration to follow-up (up to Day 23)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to Day 23)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to Day 23)
|
|
Nervous system disorders
Somnolence
|
16.7%
2/12 • Number of events 2 • From start of study drug administration to follow-up (up to Day 23)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to Day 23)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to Day 23)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to Day 23)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER