NCT05382104

Maribavir Food-Effect Study in Healthy Adults Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Maribavir	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.

Timeline

• Start date: 2022-05-25
• Primary completion: 2022-07-02
• Completion: 2022-07-02
• First posted: 2022-05-19
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study