Maribavir Food-Effect Study in Healthy Adults Participants

NCT05382104 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-620-1025
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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. 1.Fasting (Treatment A),
2. 2.Fed following a low-fat/low-calorie meal (Treatment B), and
3. 3.Fed following a high fat/high-calorie meal (Treatment C).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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)

• Number of Participants Based on Severity of TEAEs

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

• Number of Participants Based on Causality of TEAEs

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

Study Arms (6)

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.

Drug: Maribavir

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.

Drug: Maribavir

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.

Drug: Maribavir

Sequence 4: Treatment B + Treatment C + Treatment A

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.

Drug: Maribavir

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.

Drug: Maribavir

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.

Drug: Maribavir

Interventions

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.

Also known as: TAK-620

Sequence 1: Treatment A + Treatment B + Treatment C; Sequence 2: Treatment A + Treatment C + Treatment B; Sequence 3: Treatment B + Treatment A + Treatment C; Sequence 4: Treatment B + Treatment C + Treatment A; Sequence 5: Treatment C + Treatment A + Treatment B; Sequence 6: Treatment C + Treatment B + Treatment A

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

maribavir

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: May 25, 2022
• Primary Completion: July 2, 2022
• Study Completion: July 2, 2022
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

US (1)