| Primary | Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter (mcg/mL) | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00010.7± 31.42
- OG0017.35± 46.92
- OG0026.84± 56.71
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANOVA | | | | % Ratio of Geometric least square means | 67.76 | | | 2-Sided | 90 | 59.50 | 77.16 | | | | | Equivalence | Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters. | |
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| Primary | Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma | tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported. | 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. | Posted | | Median | Full Range | Hour | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma | AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*micrograms per milliliter (h*μg/mL) | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma | AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*μg/mL | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma | t1/2 of maribavir in plasma was reported. | 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. | Posted | | Median | Full Range | Hour | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma | CL/F of maribavir in Plasma was reported. | 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. | Posted | | Mean | Standard Deviation | Liters per hour (L/h) | | 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 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma | Tlag of maribavir in plasma was reported. | 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. | Posted | | Median | Full Range | Hour | | 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 7 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7 | 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. | 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. | Posted | | Count of Participants | | Participants | | Up to Day 7 | | | | ID | Title | Description |
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| OG000 | Treatment A | Participants received 200 milligrams (mg) of maribavir tablet orally on Day 1 or Day 4 or Day 7. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Safety Set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (Day 17) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs | 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. | Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (Day 17) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs | 12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE. | Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (Day 17) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs | 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. | Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1. | Posted | | Count of Participants | | Participants | | From start of study drug administration up to follow-up (Day 17) | | | | ID | Title | Description |
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| OG000 | 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. |
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