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A Study of Maribavir Pediatric Formulation in Healthy Adult Participants

NCT05918822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-09-26

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Maribavir Commercial Tablet Formulation

Maribavir commercial tablet.

DRUG

Maribavir Pediatric Powder-for-oral Suspension Formulation

Maribavir pediatric powder-for-oral suspension.

DRUG

Rabeprazole

Rabeprazole tablet.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2023-08-25
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918822 on ClinicalTrials.gov