A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Participants to Evaluate the Relative Bioavailability of Maribavir Pediatric Formulation Compared to the Commercial Formulation, as Well as, Food Effect, and Rabeprazole Gastric Acid-Reducing Effect on the Pharmacokinetics of Single-Dose Maribavir Pediatric Formulation

Takeda1 site in 1 country32 target enrollmentAugust 10, 2023

InterventionsMaribavir Commercial Tablet Formulation Maribavir Pediatric Powder-for-oral Suspension Formulation Rabeprazole

DrugsMaribavir Commercial Tablet Formulation Maribavir Pediatric Powder-for-oral Suspension Formulation Rabeprazole

Overview

Phase: Phase 1
Intervention: Maribavir Commercial Tablet Formulation
Conditions: Healthy Volunteers
Sponsor: Takeda
Enrollment: 32
Locations: 1
Primary Endpoint: Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part.

The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in the digestive tract compared to commercial tablet formulation and to check how a high-fat, high-calorie meal affects absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension.

The main aim of Part 2 of this study is to assess the stomach acid reducing effect of multiple doses of rabeprazole on absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension.

Each participant will stay in the study clinic from the day before the first treatment until the day after the last treatment.

Detailed Description

Part 1 is a crossover design with three treatments (Treatments A, B, and C), six sequences, and three periods. The relative bioavailability of 200 milligrams (mg) maribavir pediatric formulation administered orally as water suspension under fasting conditions (Treatment B) will be compared to 200 mg maribavir commercial tablet administered orally under fasting conditions (Treatment A). In addition, the effect of food on the pharmacokinetics (PK) of 200 mg maribavir pediatric formulation administered orally as water suspension under fasting conditions (Treatment B) and fed conditions (Treatment C) will be assessed. In each sequence, participants will receive three treatments (Treatments A, B, and C) per schedule. * 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 Part 2 is a single fixed-sequence design with two treatments (Treatments D and E). The two treatments will be administered to evaluate the gastric acid-reducing effect of multiple doses of rabeprazole on the PK of a single dose of 200 mg maribavir pediatric formulation administered orally as water suspension.

Registry

clinicaltrials.gov

Start Date

August 10, 2023

End Date

August 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Takeda

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•An understanding, ability, and willingness to fully comply with study procedures and restrictions and to voluntarily sign (personally or via a legally authorized representative) informed consent form to participate in the study.
•Age 18 to 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.
•Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), inclusive with a body weight greater than (\>) 50 kilograms (kg) (110 pounds \[lbs\]), at the screening visit.
•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
•Ability to swallow a dose of maribavir or rabeprazole.

Exclusion Criteria

•History or presence of gastritis, gastrointestinal (GI) tract disorder, hepatic disorder or cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in the opinion of the investigator or designee, may affect the absorption, distribution, metabolism, or elimination of the study drugs.
•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 study drugs, 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 study drugs or procedures.
•Known or suspected intolerance or hypersensitivity to maribavir or rabeprazole (Part 2 only), 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 investigational drug (ID).
•Has diarrhea within 4 hours of the first dose of the ID.
•Donation of blood or blood products (example, 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, in the Investigator or designee's opinion, may impact this Takeda-sponsored study.

Arms & Interventions

Part 1, Sequence 1: Treatment A + Treatment B + Treatment C

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.

Intervention: Maribavir Commercial Tablet Formulation