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Healthy VolunteersPhase 1NCT05382104

Maribavir Food-Effect Study in Healthy Adults Participants

A Phase 1 study testing Maribavir in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Maribavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
25 May 2022to 2 Jul 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must fulfill the following inclusion criteria before the first dose of the Investigational drug (ID) to be eligible for participation in the study:
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions and ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent
  • Age 19-55 years, inclusive at the time of consent, at the screening visit.
  • Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or female of non-childbearing potential.
  • Healthy as determined by the Investigator or designee on the basis of screening evaluations and medical history.
  • Hemoglobin for males greater than or equal to (>=) 135.0 gram per liter (g/L) and females >=120.0 g/L at the screening visit and on Day 1 of Treatment Period 1.
  • Body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive with a body weight greater than (>) 50 kilogram (kg) (110 pound [lbs]), at the screening visit.
  • Ability to swallow a dose of the ID.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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:
  • Have used any investigational product (if elimination half-life is less than [<] 6 days, otherwise 5 half-lives).
  • Have been enrolled in a clinical study (including vaccine studies) that may impact this study.
  • Have had any substantial changes in eating habits.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants

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:

Read more
  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.

Being tested
Maribavir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaribavirDrug

    Also called TAK-620

    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.

Study groups in NCT05382104
Study groupRoleWhat they receive
Sequence 1: Treatment A + Treatment B + Treatment CExperimentalParticipants 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.
Receives: Drug: Maribavir
Sequence 2: Treatment A + Treatment C + Treatment BExperimentalParticipants 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.
Receives: Drug: Maribavir
Sequence 3: Treatment B + Treatment A + Treatment CExperimentalParticipants 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.
Receives: Drug: Maribavir
Sequence 4: Treatment B + Treatment C + Treatment AExperimentalParticipants 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.
Receives: Drug: Maribavir
Sequence 5: Treatment C + Treatment A + Treatment BExperimentalParticipants 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.
Receives: Drug: Maribavir
Sequence 6: Treatment C + Treatment B + Treatment AExperimentalParticipants 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.
Receives: Drug: Maribavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of Maribavir

    Cmax of maribavir in plasma was reported using the non-compartmental analysis.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

Secondary outcomes (3)

  1. 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.

    Measured: From start of study drug administration to follow-up (up to Day 18)

  2. 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.

    Measured: From start of study drug administration to follow-up (up to Day 18)

  3. 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.

    Measured: From start of study drug administration to follow-up (up to Day 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start25 May 2022
  3. Primary completion2 Jul 2022
  4. Study completion2 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382104
Sponsor's protocol ID
TAK-620-1025
Status last verified
Jun 2023
First submitted
16 May 2022
Last updated
16 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38708555

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Maribavir in people with Healthy Volunteers, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Maribavir (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382104, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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