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Antiviral

Part 1, Sequence 2: Treatment A + Treatment C + Treatment B for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose in each treatment period on day 1 in parts 1 and 2 and day 5 in part 2
Awards & highlights

Study Summary

This trial will examine the effects of a single dose and multiple doses of maribavir on absorption and distribution in the body, while considering the effects of a high-fat, high-calorie meal and stomach acid reducing medication. Participants will stay in the clinic from before to after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose in each treatment period on day 1 in parts 1 and 2 and day 5 in part 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose in each treatment period on day 1 in parts 1 and 2 and day 5 in part 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parts 1 and 2: Area Under the Plasma Concentration-time Curve from time 0 to infinity (AUC0-infinity) of maribavir
Parts 1 and 2: Area Under the Plasma Concentration-time Curve from time 0 to the time of the last quantifiable concentration (AUClast) of maribavir
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of maribavir
Secondary outcome measures
Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Trial Design

8Treatment groups
Experimental Treatment
Group I: Part 2: Treatment D: maribavir 200 mgExperimental Treatment1 Intervention
Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment D).
Group II: Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mgExperimental Treatment2 Interventions
Participants will receive rabeprazole single 20 mg tablet, once daily on Days 1 to 5 of Treatment Period 2 under fasting condition followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose, 2 hours after rabeprazole dosing on morning of Day 5 of Treatment Period 2 under fasting condition (Treatment E). There will be a washout period of a minimum of 72 hours between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2.
Group III: Part 1, Sequence 6: Treatment C + Treatment B+ Treatment AExperimental Treatment2 Interventions
Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition as (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment.
Group IV: Part 1, Sequence 5: Treatment C + Treatment A + Treatment BExperimental Treatment2 Interventions
Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment.
Group V: Part 1, Sequence 4: Treatment B + Treatment C + Treatment AExperimental Treatment2 Interventions
Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment.
Group VI: Part 1, Sequence 3: Treatment B + Treatment A + Treatment CExperimental Treatment2 Interventions
Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment.
Group VII: Part 1, Sequence 2: Treatment A + Treatment C + Treatment BExperimental Treatment2 Interventions
Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment.
Group VIII: Part 1, Sequence 1: Treatment A + Treatment B + Treatment CExperimental Treatment2 Interventions
Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maribavir Commercial Tablet Formulation
2023
Completed Phase 1
~40
Maribavir Pediatric Powder-for-oral Suspension Formulation
2023
Completed Phase 1
~40
Rabeprazole
2017
Completed Phase 4
~3920

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,984 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,210 Previous Clinical Trials
489,457 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What level of safety is associated with Part 1, Sequence 1: Treatment A + Treatment B + Treatment C?

"Since this is a preliminary Phase 1 trial, there are only limited clinical data points around the safety and efficacy of Part 1, Sequence 1: Treatment A + Treatment B + Treatment C. Thus, it received an overall score of 1 on our rating scale."

Answered by AI

Does your study include participants aged 65 and above?

"The cut-off for participation in this medical trial is 55 years old, with the minimum age of consent set at 18."

Answered by AI

Is there availability to join this experiment for those seeking treatment?

"According to clinicaltrials.gov, this study is not currently enrolling patients; however, it was initially posted on July 27th 2023 and last modified June 16th 2023. Fortunately, there are 788 other trials actively recruiting participants at the present time."

Answered by AI

Are my criteria sufficient to qualify me for participation in this experiment?

"This medical trial is seeking 32 individuals who are physically sound and between the ages of 18-55 to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Maribavir Pediatric Formulation in Healthy Adult Participants
2023. "A Study of Maribavir Pediatric Formulation in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918822.
~19 spots leftby Apr 2025
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