Maribavir Food-Effect Study in Healthy Adults Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Maribavir

Registration Number: NCT05382104

Lead Sponsor: Takeda

Brief Summary: 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:

1. Fasting (Treatment A),

2. Fed following a low-fat/low-calorie meal (Treatment B), and

3. Fed following a high fat/high-calorie meal (Treatment C).

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 4: Treatment B + Treatment C + Treatment A	Maribavir	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 2: Treatment A + Treatment C + Treatment B	Maribavir	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 1: Treatment A + Treatment B + Treatment C	Maribavir	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 3: Treatment B + Treatment A + Treatment C	Maribavir	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 5: Treatment C + Treatment A + Treatment B	Maribavir	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	Maribavir	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir	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	AUC0-infinity of maribavir in plasma was reported using the non-compartmental analysis.
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir	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	AUClast of maribavir in plasma was reported using the non-compartmental analysis.
Maximum Observed Plasma Concentration (Cmax) of Maribavir	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	Cmax of maribavir in plasma was reported using the non-compartmental analysis.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs	From start of study drug administration to follow-up (up to Day 18)	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.
Number of Participants Based on Severity of TEAEs	From start of study drug administration to follow-up (up to Day 18)	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.
Number of Participants Based on Causality of TEAEs	From start of study drug administration to follow-up (up to Day 18)	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.