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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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The main goals of this study are: 1) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a low-fat/low-calorie meal relative to administration under fasting conditions. 2) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a high-fat/high calorie meal relative to administration under fasting conditions.
A single dose of 400 mg maribavir (commercial [marketed] tablet formulation) will be administered orally under 3 different feeding conditions:
There will be a washout period of a minimum of 72 hours between each single dose of investigational drug (ID) administration on Day 1 in each treatment cycle of 3 days.
Pharmacokinetic samples will be collected at pre-dose and up to 36 hours post-dose in each treatment period.
Safety and tolerability will be assessed throughout the study by Treatment Emergent Adverse Events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Treatment A + Treatment B + Treatment C | Experimental | Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of 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 Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of minimum of 72 hours between each ID dosing. |
|
| Sequence 2: Treatment A + Treatment C + Treatment B | Experimental | Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet on Day 1 of Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a low fat/low calorie meal (Treatment B). There will be a washout period of minimum of 72 hours between each ID dosing. |
|
| Sequence 3: Treatment B + Treatment A + Treatment C | Experimental | Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of minimum of 72 hours between each ID dosing. |
|
| Sequence 4: Treatment B + Treatment C + Treatment A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maribavir | Drug | Maribavir single 400 mg tablet under three different food conditions (fasted, low fat/low calorie meal, and high fat/high calorie meal) depending upon the treatment sequence allocation on Day 1 of each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Maribavir | Cmax of maribavir in plasma was reported using the non-compartmental analysis. | 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 |
| Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir | AUClast of maribavir in plasma was reported using the non-compartmental analysis. | 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 |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir | AUC0-infinity of maribavir in plasma was reported using the non-compartmental analysis. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs | 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. |
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Inclusion Criteria
Participants must fulfill the following inclusion criteria before the first dose of the Investigational drug (ID) to be eligible for participation in the study:
Exclusion Criteria
Participants must not be enrolled in the study if they meet any of the following criteria before the first dose of the ID:
History or presence of gastritis, Gastrointestinal (GI) tract, hepatic disorder or cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease or other clinical GI condition and history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current recurrent disease that could affect the action, absorption, or disposition of the ID, or clinical or laboratory assessments.
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 ID or procedures.
Known or suspected intolerance or hypersensitivity to the ID, closely related compounds, or any of the stated ingredients and excipients.
Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose of the ID.
Has diarrhea within 4 hours of the first dose of the ID.
Donors of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of the ID.
Within 30 days prior to the first dose of the ID:
Systolic blood pressure >140 millimeters of mercury (mmHg) or <90 mmHg, and diastolic blood pressure >90 mmHg or <50 mmHg, at the screening visit.
Twelve-lead ECG with corrected QT interval (QTc) >450 millisecond (msec) at the screening visit.
Known history of alcohol or other substance abuse 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 screen for alcohol or drugs of abuse at the screening visit or on Day -1 of Treatment Period 1.
A positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen at the screening visit.
Use of tobacco in any form or other nicotine-containing products in any form. Ex-users must self-report that they have stopped using tobacco for at least 3 months prior to receiving the first dose of the ID.
Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. Decaffeinated coffee, tea, or cola are not considered to contain caffeine.
Current use of any prescription medication with the exception of hormonal contraceptives and hormonal replacement therapy.
Current use of antacids, proton pump inhibitors, or H2 antagonists within 14 days of the first dose of the ID.
Inability or unwillingness to consume 100 percent of high-fat meal or low-fat meal (including participants with lactose or gluten intolerance).
Recent history (within 1 month) of oral/nasal cavity infections, history of gastroesophageal reflux, asthma treatment with albuterol, or zinc supplementation.
Participants with dry mouth syndrome or burning mouth syndrome or participants suffering from dysgeusia.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38708555 | Derived | Sun K, Ilic K, Xu P, Ye R, Wu J, Song IH. Effect of Food, Crushing of Tablets, and Antacid Coadministration on Maribavir Pharmacokinetics in Healthy Adult Participants: Results From 2 Phase 1, Open-Label, Randomized, Crossover Studies. Clin Pharmacol Drug Dev. 2024 Jun;13(6):644-654. doi: 10.1002/cpdd.1406. Epub 2024 May 6. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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).
This study was conducted at single center in the United States from 25 May 2022 to 02 July 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (2 Days) |
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| Washout Period 1 (72 Hours) |
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| Period 2 (2 Days) |
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| Washout Period 2 (72 Hours) |
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| Period 3 (2 Days) |
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The safety set included all participants who received at least 1 dose of maribavir.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Maribavir | Cmax of maribavir in plasma was reported using the non-compartmental analysis. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | 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 |
|
From start of study drug administration to follow-up (up to Day 18)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: Maribavir 400 mg | Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2022 | May 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2022 | May 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C400401 | maribavir |
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| Experimental |
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 under fasting condition (Treatment A). There will be a washout period of minimum of 72 hours between each ID dosing. |
|
| Sequence 5: Treatment C + Treatment A + Treatment B | Experimental | Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a low fat/low calorie meal (Treatment B). There will be a washout period of minimum of 72 hours between each ID dosing. |
|
| Sequence 6: Treatment C + Treatment B + Treatment A | Experimental | Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 administered with a low fat/low calorie meal (Treatment B), and followed by maribavir single 400 mg tablet on Day 1 of Period 3 under fasting condition (Treatment A). There will be a washout period of minimum of 72 hours between each ID dosing. |
|
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| From start of study drug administration to follow-up (up to Day 18) |
| Number of Participants Based on Severity of TEAEs | 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. | From start of study drug administration to follow-up (up to Day 18) |
| Number of Participants Based on Causality of TEAEs | 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. | From start of study drug administration to follow-up (up to Day 18) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Treatment B: Maribavir 400 mg |
Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3. |
| OG002 | Treatment C: Maribavir 400 mg | Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3. |
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| Primary | Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir | AUClast of maribavir in plasma was reported using the non-compartmental analysis. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter(mcg*hr/mL) | 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 |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir | AUC0-infinity of maribavir in plasma was reported using the non-compartmental analysis. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | 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 |
|
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|
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| Secondary | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs | 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. | The safety set included all participants who received at least 1 dose of maribavir. | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to Day 18) |
|
|
|
| Secondary | Number of Participants Based on Severity of TEAEs | 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. | The safety set included all participants who received at least 1 dose of maribavir. | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to Day 18) |
|
|
|
| Secondary | Number of Participants Based on Causality of TEAEs | 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. | The safety set included all participants who received at least 1 dose of maribavir. | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to Day 18) |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 7 |
| 31 |
| EG001 | Treatment B: Maribavir 400 mg | Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3. | 0 | 30 | 0 | 30 | 9 | 30 |
| EG002 | Treatment C: Maribavir 400 mg | Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3. | 0 | 31 | 0 | 31 | 7 | 31 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
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.
| Geometric Mean Ratio (%) | 87.35 | 2-Sided | 90 | 83.87 | 90.96 | Geometric mean ratio (%) was calculated as 100*(Treatment C / Treatment A). | Equivalence | A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A. |
| Geometric Mean Ratio (%) | 87.84 | 2-Sided | 90 | 84.30 | 91.53 | Geometric mean ratio (%) was calculated as 100*(Treatment C / Treatment A). | Equivalence | A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A. |
| Title | Measurements |
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| Title | Measurements |
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| Severe |
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| Title | Measurements |
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