Trial Outcomes & Findings for A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants (NCT NCT04131556)
NCT ID: NCT04131556
Last Updated: 2025-09-02
Results Overview
Cmax defined as maximum concentration occurred at tmax of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
TERMINATED
PHASE1
20 participants
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7
2025-09-02
Participant Flow
This study was conducted at single site in United States of America from 25 October 2019 (first participant first visit) and 06 January 2020 (last participant last visit).
This study was planned to be conducted in 2 parts: Part 1 and Part 2. However, study was terminated based on planned interim analysis of the data of Part 1, palatability of both pediatric formulations was not acceptable and therefore, Part 2 was not conducted. Participants were randomized to 1 of 6 sequences with treatment A, B and C. Baseline characteristics of participants were only analyzed and reported for overall study period, as planned, and not per treatment to avoid double-counting.
Participant milestones
| Measure |
Maribavir
Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Maribavir
Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Maribavir
n=20 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
|
|---|---|
|
Age, Continuous
|
33.7 Years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7Population: Pharmacokinetic (PK) set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
Cmax defined as maximum concentration occurred at tmax of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
|
10.7 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31.42
|
7.35 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 46.92
|
6.84 Micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 56.71
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7Population: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
|
1.00 Hour
Interval 0.5 to 2.0
|
3.00 Hour
Interval 1.0 to 4.0
|
2.00 Hour
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7Population: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma
|
50.1 Hour*micrograms per milliliter (h*μg/mL)
Geometric Coefficient of Variation 49.21
|
41.2 Hour*micrograms per milliliter (h*μg/mL)
Geometric Coefficient of Variation 55.09
|
39.1 Hour*micrograms per milliliter (h*μg/mL)
Geometric Coefficient of Variation 60.58
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7Population: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma
|
52.5 h*μg/mL
Geometric Coefficient of Variation 49.72
|
44.5 h*μg/mL
Geometric Coefficient of Variation 56.26
|
42.4 h*μg/mL
Geometric Coefficient of Variation 60.69
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7Population: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
t1/2 of maribavir in plasma was reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma
|
4.04 Hour
Interval 1.33 to 8.07
|
4.80 Hour
Interval 1.9 to 11.6
|
5.95 Hour
Interval 1.36 to 10.1
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7Population: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
CL/F of maribavir in Plasma was reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma
|
4.21 Liters per hour (L/h)
Standard Deviation 1.99
|
5.13 Liters per hour (L/h)
Standard Deviation 2.82
|
5.49 Liters per hour (L/h)
Standard Deviation 3.29
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Day 1, 4 and 7Population: PK set 1 consisted of participants who received at least 1 dose of maribavir, did not vomit within 4 hours post dosing, and had at least 1 evaluable post-dose maribavir concentration value in Part 1. Data for the PK parameters were planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
Tlag of maribavir in plasma was reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma
|
0.00 Hour
Interval 0.0 to 0.25
|
0.250 Hour
Interval 0.0 to 0.5
|
0.250 Hour
Interval 0.0 to 0.5
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1. Data for the palatability was planned and analyzed based on unique treatment sequence A, B, C. Hence, data was reported separately.
The palatability was evaluated to identify, characterize and quantify the sensory attributes of products, e.g., basic tastes, texture and mouth feel and to assess the overall acceptability. Number of participants responded to palatability assessment up to Day 7 were reported.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
n=19 Participants
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
n=20 Participants
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
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Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How this drug tasted to you?: Bitter
|
2 Participants
|
14 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How this drug tasted to you?: Salty
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How this drug tasted to you?: Sour
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How this drug tasted to you?: Sweet
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How this drug tasted to you?: Savory
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How this drug tasted to you?: No taste
|
16 Participants
|
4 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How strong was the taste?: Strong
|
0 Participants
|
8 Participants
|
8 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How strong was the taste?: Medium
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How strong was the taste?: Weak
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
How strong was the taste?: no taste
|
16 Participants
|
4 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Did the drug have a rough or gritty texture?: No
|
18 Participants
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Did the drug have a rough or gritty texture?: Yes
|
0 Participants
|
15 Participants
|
16 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Was the drug easy to swallow?: No
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Was the drug easy to swallow?: Yes
|
18 Participants
|
19 Participants
|
20 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Overall taste & texture?: Agree
|
18 Participants
|
10 Participants
|
13 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Overall taste & texture?: Neither agree/disagree
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7
Overall taste & texture?: Disagree
|
0 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 17)Population: Safety Set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1.
An adverse event (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 treatment. A TEAE was an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. Number of participants with TEAEs were reported.
Outcome measures
| Measure |
Treatment A
n=20 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 17)Population: Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1.
Vital sign assessments included systolic and diastolic blood pressure, pulse rate and body temperature. Any change in vital signs which were deemed clinically significant by the investigator were recorded as TEAE.
Outcome measures
| Measure |
Treatment A
n=20 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 17)Population: Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1.
12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 17)Population: Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1.
Clinical laboratory tests included biochemistry, hematology and urinalysis. Any change in clinical laboratory results which are deemed clinically significant by the investigator were reported as TEAE.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7.
|
Treatment B
Participants received 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading on Day 1 or Day 4 or Day 7.
|
Treatment C
Participants received maribavir 200 mg powder for oral suspension with 36.1% drug loading on Day 1 or Day 4 or Day 7.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs
|
0 Participants
|
—
|
—
|
Adverse Events
Maribavir
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maribavir
n=20 participants at risk
Participants received 200 milligrams (mg) of maribavir tablet orally (Treatment A) or 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Treatment B) or maribavir 200 mg powder for oral suspension with 36.1% drug loading (Treatment C) on Day 1 or Day 4 or Day 7 in different sequences of ABC, BCA, CAB, CBA, ACB, and BAC.
|
|---|---|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to follow-up (Day 17)
|
|
Investigations
Liver function test increased
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to follow-up (Day 17)
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • From start of study drug administration up to follow-up (Day 17)
|
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