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Sequence 6: Treatment C + Treatment B + Treatment A 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 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
Awards & highlights

Study 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: Fasting (Treatment A), Fed following a low-fat/low-calorie meal (Treatment B), and 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir
Maximum Observed Plasma Concentration (Cmax) of Maribavir
Secondary outcome measures
Number of Participants Based on Causality of TEAEs
Number of Participants Based on Severity of TEAEs
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs

Side effects data

From 2022 Phase 3 trial • 553 Patients • NCT02927067
53%
Neutropenia
23%
Thrombocytopenia
23%
Nausea
18%
Anaemia
17%
Vomiting
16%
Diarrhoea
12%
Acute graft versus host disease in skin
11%
Neutrophil count decreased
10%
Leukopenia
9%
Pyrexia
9%
Cough
9%
Oedema peripheral
8%
Hypokalaemia
7%
Abdominal pain
7%
Asthenia
7%
Fatigue
6%
Decreased appetite
6%
Dysgeusia
6%
Hypertension
6%
Platelet count decreased
6%
Pruritus
5%
Dyspnoea
5%
Headache
5%
Renal impairment
5%
Tremor
5%
White blood cell count decreased
4%
Blood creatinine increased
4%
Constipation
3%
Febrile neutropenia
2%
Cystitis haemorrhagic
2%
Taste disorder
1%
Acute graft versus host disease in intestine
1%
Acute lymphocytic leukaemia recurrent
1%
Cytomegalovirus infection
1%
Cytomegalovirus viraemia
1%
Pneumonia
1%
Pneumonia cytomegaloviral
1%
Pseudomonal sepsis
1%
Respiratory tract infection
1%
Acute myeloid leukaemia recurrent
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valganciclovir 900 mg BID
Maribavir 400 mg BID

Trial Design

6Treatment groups
Experimental Treatment
Group I: Sequence 6: Treatment C + Treatment B + Treatment AExperimental Treatment1 Intervention
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.
Group II: Sequence 5: Treatment C + Treatment A + Treatment BExperimental Treatment1 Intervention
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.
Group III: Sequence 4: Treatment B + Treatment C + Treatment AExperimental Treatment1 Intervention
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.
Group IV: Sequence 3: Treatment B + Treatment A + Treatment CExperimental Treatment1 Intervention
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.
Group V: Sequence 2: Treatment A + Treatment C + Treatment BExperimental Treatment1 Intervention
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.
Group VI: Sequence 1: Treatment A + Treatment B + Treatment CExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maribavir
2017
Completed Phase 3
~1230

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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
1,203 Previous Clinical Trials
4,177,994 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,003 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,322 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Apr 2025