NCT04131556

A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants

Terminated Phase 1 Results posted Last updated 2 September 2025

What this trial tests

Phase 1 trial testing Maribavir in Healthy Volunteers in 20 participants. Terminated before completion.

Timeline

25 October 2019

Primary endpoint
6 January 2020

6 January 2020

Quick facts

Lead sponsor	Shire
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	25 October 2019
Primary completion	6 January 2020
Estimated completion	6 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Maribavir (MARIBAVIR) — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7

Cmax defined as maximum concentration occurred at tmax of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.

Group	Value	95% CI
Treatment A	10.7	± 31.42
Treatment B	7.35	± 46.92
Treatment C	6.84	± 56.71

Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7

tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported.

Group	Value	95% CI
Treatment A	1.00	0.500 – 2.00
Treatment B	3.00	1.00 – 4.00
Treatment C	2.00	1.00 – 4.00

Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7

AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.

Group	Value	95% CI
Treatment A	50.1	± 49.21
Treatment B	41.2	± 55.09
Treatment C	39.1	± 60.58

Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4, and 7

AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.

Group	Value	95% CI
Treatment A	52.5	± 49.72
Treatment B	44.5	± 56.26
Treatment C	42.4	± 60.69

Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7

t1/2 of maribavir in plasma was reported.

Group	Value	95% CI
Treatment A	4.04	1.33 – 8.07
Treatment B	4.80	1.90 – 11.6
Treatment C	5.95	1.36 – 10.1

Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Days 1, 4 and 7

CL/F of maribavir in Plasma was reported.

Group	Value	95% CI
Treatment A	4.21	± 1.99
Treatment B	5.13	± 2.82
Treatment C	5.49	± 3.29

Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma Primary · Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24 hours post-dose on Day 1, 4 and 7

Tlag of maribavir in plasma was reported.

Group	Value	95% CI
Treatment A	0.00	0.00 – 0.250
Treatment B	0.250	0.00 – 0.500
Treatment C	0.250	0.00 – 0.500

Part 1: Number of Participants With Responses to Palatability Assessment up to Day 7 Primary · Up to Day 7

The palatability was evaluated to identify, characterize and quantify the sensory attributes of products, e.g., basic tastes, texture and mouth feel and to assess the overall acceptability. Number of participants responded to palatability assessment up to Day 7 were reported.

How this drug tasted to you?: Bitter

Group	Value	95% CI
Treatment A	2
Treatment B	14
Treatment C	14

How this drug tasted to you?: Salty

Group	Value	95% CI
Treatment A	0
Treatment B	0
Treatment C	1

How this drug tasted to you?: Sour

Group	Value	95% CI
Treatment A	0
Treatment B	1
Treatment C	0

How this drug tasted to you?: Sweet

Group	Value	95% CI
Treatment A	0
Treatment B	0
Treatment C	0

How this drug tasted to you?: Savory

Group	Value	95% CI
Treatment A	0
Treatment B	0
Treatment C	0

How this drug tasted to you?: No taste

Group	Value	95% CI
Treatment A	16
Treatment B	4
Treatment C	5

How strong was the taste?: Strong

Group	Value	95% CI
Treatment A	0
Treatment B	8
Treatment C	8

How strong was the taste?: Medium

Group	Value	95% CI
Treatment A	1
Treatment B	6
Treatment C	3

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · From start of study drug administration up to follow-up (Day 17)

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this treatment. A TEAE was an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. Number of participants with TEAEs were reported.

Group	Value	95% CI
Maribavir	3

Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs Secondary · From start of study drug administration up to follow-up (Day 17)

Vital sign assessments included systolic and diastolic blood pressure, pulse rate and body temperature. Any change in vital signs which were deemed clinically significant by the investigator were recorded as TEAE.

Group	Value	95% CI
Maribavir	0

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs Secondary · From start of study drug administration up to follow-up (Day 17)

12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE.

Group	Value	95% CI
Maribavir	0

Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs Secondary · From start of study drug administration up to follow-up (Day 17)

Clinical laboratory tests included biochemistry, hematology and urinalysis. Any change in clinical laboratory results which are deemed clinically significant by the investigator were reported as TEAE.

Group	Value	95% CI
Maribavir	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study drug administration up to follow-up (Day 17). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Maribavir

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (3 terms — click to expand)

Reaction	System	Maribavir
Flatulence	Gastrointestinal disorders	—
Liver function test increased	Investigations	—
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04131556 adverse events section.

Sponsor's own description

The Purpose of this study is to assess the relative bioavailability, dose proportionality, the impact of food on the rate and extent of absorption, palatability of the selected pediatric formulation of maribavir and the safety and tolerability of two candidate pediatric formulations and the adult tablet formulation of maribavir in healthy participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.