Trial Outcomes & Findings for Maribavir Food-Effect Study in Healthy Adults Participants (NCT NCT05382104)
NCT ID: NCT05382104
Last Updated: 2024-02-16
Results Overview
Cmax of maribavir in plasma was reported using the non-compartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Day 1: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dose
Results posted on
2024-02-16
Participant Flow
This study was conducted at single center in the United States from 25 May 2022 to 02 July 2022.
A total of 31 healthy participants were enrolled in this 3-period crossover study and were randomized to 1 of 6 treatment sequences to receive maribavir 400 milligrams (mg) tablet in fasting state (Treatment A), fed following a low-fat/low-calorie meal (Treatment B) or fed following a high-fat/high-calorie meal (Treatment C).
Participant milestones
| Measure |
Sequence 1: Treatment A + Treatment B + Treatment C
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a low fat/low calorie meal (Treatment B), and further followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). A washout period of minimum of 72 hours between each investigational drug (ID) dosing was maintained.
|
Sequence 2: Treatment A + Treatment C + Treatment B
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a low fat/low calorie meal (Treatment B). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 3: Treatment B + Treatment A + Treatment C
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 4: Treatment B + Treatment C + Treatment A
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 5: Treatment C + Treatment A + Treatment B
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a low fat/low calorie meal (Treatment B). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 6: Treatment C + Treatment B + Treatment A
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a low fat/low calorie meal (Treatment B), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
|---|---|---|---|---|---|---|
|
Period 1 (2 Days)
STARTED
|
5
|
6
|
5
|
5
|
5
|
5
|
|
Period 1 (2 Days)
COMPLETED
|
5
|
6
|
5
|
5
|
5
|
5
|
|
Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (72 Hours)
STARTED
|
5
|
6
|
5
|
5
|
5
|
5
|
|
Washout Period 1 (72 Hours)
COMPLETED
|
5
|
6
|
5
|
5
|
5
|
5
|
|
Washout Period 1 (72 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (2 Days)
STARTED
|
5
|
6
|
5
|
5
|
5
|
5
|
|
Period 2 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (72 Hours)
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 2 (72 Hours)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 2 (72 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (2 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period 3 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Treatment A + Treatment B + Treatment C
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a low fat/low calorie meal (Treatment B), and further followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). A washout period of minimum of 72 hours between each investigational drug (ID) dosing was maintained.
|
Sequence 2: Treatment A + Treatment C + Treatment B
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a low fat/low calorie meal (Treatment B). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 3: Treatment B + Treatment A + Treatment C
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 4: Treatment B + Treatment C + Treatment A
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 5: Treatment C + Treatment A + Treatment B
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a low fat/low calorie meal (Treatment B). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 6: Treatment C + Treatment B + Treatment A
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a low fat/low calorie meal (Treatment B), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
|---|---|---|---|---|---|---|
|
Period 2 (2 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Maribavir Food-Effect Study in Healthy Adults Participants
Baseline characteristics by cohort
| Measure |
Sequence 1: Treatment A + Treatment B + Treatment C
n=5 Participants
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a low fat/low calorie meal (Treatment B), and further followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). A washout period of minimum of 72 hours between each investigational drug (ID) dosing was maintained.
|
Sequence 2: Treatment A + Treatment C + Treatment B
n=6 Participants
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a low fat/low calorie meal (Treatment B). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 3: Treatment B + Treatment A + Treatment C
n=5 Participants
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 4: Treatment B + Treatment C + Treatment A
n=5 Participants
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 5: Treatment C + Treatment A + Treatment B
n=5 Participants
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 administered with a low fat/low calorie meal (Treatment B). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Sequence 6: Treatment C + Treatment B + Treatment A
n=5 Participants
Participants received maribavir single 400 mg tablet, on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 2 administered with a low fat/low calorie meal (Treatment B), and followed by maribavir single 400 mg tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). A washout period of minimum of 72 hours between each ID dosing was maintained.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 6.35 • n=7 Participants
|
26.0 years
STANDARD_DEVIATION 5.61 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 11.48 • n=4 Participants
|
39.2 years
STANDARD_DEVIATION 7.92 • n=21 Participants
|
42.8 years
STANDARD_DEVIATION 10.26 • n=8 Participants
|
35.2 years
STANDARD_DEVIATION 9.57 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
29 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dosePopulation: The pharmacokinetic (PK) set included all participants who received at least 1 dose of maribavir, did not vomit or had diarrhea within 4 hours of the ID dosing, and had 5 or more post-dose time points with evaluable post-dose maribavir concentration values.
Cmax of maribavir in plasma was reported using the non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=29 Participants
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Maribavir
|
17.8 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 28.9
|
13.4 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 23.3
|
12.7 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 21.0
|
PRIMARY outcome
Timeframe: Day 1: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dosePopulation: The PK set included all participants who received at least 1 dose of maribavir, did not vomit or had diarrhea within 4 hours of the ID dosing, and had 5 or more post-dose time points with evaluable post-dose maribavir concentration values.
AUClast of maribavir in plasma was reported using the non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=29 Participants
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
|
103 microgram*hour per milliliter(mcg*hr/mL)
Geometric Coefficient of Variation 30.0
|
85.6 microgram*hour per milliliter(mcg*hr/mL)
Geometric Coefficient of Variation 34.0
|
90.0 microgram*hour per milliliter(mcg*hr/mL)
Geometric Coefficient of Variation 33.2
|
PRIMARY outcome
Timeframe: Day 1: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dosePopulation: The PK set included all participants who received at least 1 dose of maribavir, did not vomit or had diarrhea within 4 hours of the ID dosing, and had 5 or more post-dose time points with evaluable post-dose maribavir concentration values.
AUC0-infinity of maribavir in plasma was reported using the non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=29 Participants
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir
|
106 mcg*hr/mL
Geometric Coefficient of Variation 29.6
|
88.7 mcg*hr/mL
Geometric Coefficient of Variation 34.3
|
93.2 mcg*hr/mL
Geometric Coefficient of Variation 33.4
|
SECONDARY outcome
Timeframe: From start of study drug administration to follow-up (up to Day 18)Population: The safety set included all participants who received at least 1 dose of maribavir.
TEAEs were defined as adverse events (AEs) with a start date on or after the first dose of the ID, or with a start date before the date of first dose of the ID but increasing in severity after the first dose of the ID. An SAE was 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 abnormality or birth defect, an important medical event. Any clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), and clinical laboratory results were reported as TEAEs. Number of participants who experienced at least one TEAEs and serious TEAE were reported.
Outcome measures
| Measure |
Treatment A: Maribavir 400 mg
n=31 Participants
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=31 Participants
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs
TEAEs
|
11 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration to follow-up (up to Day 18)Population: The safety set included all participants who received at least 1 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. Number of participants based on severity of TEAEs as assessed by the Investigator were reported.
Outcome measures
| Measure |
Treatment A: Maribavir 400 mg
n=31 Participants
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=31 Participants
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Number of Participants Based on Severity of TEAEs
Mild
|
11 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants Based on Severity of TEAEs
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Based on Severity of TEAEs
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration to follow-up (up to Day 18)Population: The safety set included all participants who received at least 1 dose of maribavir.
The causality relationship of each AE to the ID 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.
Outcome measures
| Measure |
Treatment A: Maribavir 400 mg
n=31 Participants
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=30 Participants
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=31 Participants
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Number of Participants Based on Causality of TEAEs
Related TEAEs
|
8 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants Based on Causality of TEAEs
Not Related TEAEs
|
3 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Treatment A: Maribavir 400 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment B: Maribavir 400 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment C: Maribavir 400 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Maribavir 400 mg
n=31 participants at risk
Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment B: Maribavir 400 mg
n=30 participants at risk
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
Treatment C: Maribavir 400 mg
n=31 participants at risk
Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3.
|
|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
19.4%
6/31 • From start of study drug administration to follow-up (up to Day 18)
|
26.7%
8/30 • From start of study drug administration to follow-up (up to Day 18)
|
16.1%
5/31 • From start of study drug administration to follow-up (up to Day 18)
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • From start of study drug administration to follow-up (up to Day 18)
|
0.00%
0/30 • From start of study drug administration to follow-up (up to Day 18)
|
0.00%
0/31 • From start of study drug administration to follow-up (up to Day 18)
|
|
General disorders
Fatigue
|
6.5%
2/31 • From start of study drug administration to follow-up (up to Day 18)
|
0.00%
0/30 • From start of study drug administration to follow-up (up to Day 18)
|
3.2%
1/31 • From start of study drug administration to follow-up (up to Day 18)
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • From start of study drug administration to follow-up (up to Day 18)
|
6.7%
2/30 • From start of study drug administration to follow-up (up to Day 18)
|
9.7%
3/31 • From start of study drug administration to follow-up (up to Day 18)
|
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