NCT05918822

A Study of Maribavir Pediatric Formulation in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-25
• Primary completion: 2023-08-25
• Completion: 2023-09-01
• First posted: 2023-06-26
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study