A Phase 1 interventional study of Maribavir in Healthy Volunteers, sponsored by Shire. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Shire · Phase 1, Interventional, and Treatment
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.
The study will be conducted in two parts (Part 1 and Part 2). Part 1 consists of three treatment periods in six sequences and part 2 consists of four treatment periods in four sequences. In Part 1 two pediatric candidate powder formulations will be compared with maribavir 200mg tablet under fasted conditions in regards to their bioavailability and palatability. In Part 2 dose proportionality and impact of food (a high-fat meal) on the rate and extent of absorption of the selected pediatric formulation will be assessed. The pediatric formulation which will be evaluated in Part 2 will be chosen based on the results of planned analysis of Part 1 PK and palatability data from two candidate pediatric formulations and the doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
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Exclusion Criteria:
Participants will receive 200 milligram (mg) of maribavir tablet orally (Sequence A) on Day 1 followed by 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Sequence B) on Day 4 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Drug: Maribavir
Participants will receive 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 1 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 4 and followed by 200 mg of maribavir tablet orally (Sequence A) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Drug: Maribavir
Participants will receive maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 1 followed by 200 mg of maribavir tablet orally (Sequence A) on Day 4 and followed by 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Drug: Maribavir
Participants will receive maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 1 followed by 200 mg maribavir powder for oral suspension with 32.5 percent (%) drug loading (Sequence B) on Day 4 and followed by 200 mg of maribavir tablet orally (Sequence A) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Drug: Maribavir
Participants will receive 200 mg of maribavir tablet orally (Sequence A) on Day 1 followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 4 and followed by 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 7 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Drug: Maribavir
Participants will receive 200 mg maribavir powder for oral suspension with 32.5 % drug loading (Sequence B) on Day 1 followed by 200 mg of maribavir tablet orally (Sequence A) on Day 4 and followed by maribavir 200 mg powder for oral suspension with 36.1% drug loading (Sequence C) on Day 7 and with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4 and 7.
Drug: Maribavir
Participants under fast will receive 50 mg of maribavir powder for oral suspension (Sequence D) on Day 1 followed by 100 mg of maribavir powder for oral suspension (Sequence E) on Day 4 followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 7 and then followed by participants under fast will receive 200 mg of maribavir powder for oral suspension (Sequence F) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Drug: Maribavir
Participants under fast will receive 100 mg of maribavir powder for oral suspension (Sequence E) on Day 1 followed by 200 mg of maribavir powder for oral suspension (Sequence F) on Day 4 followed by 50 mg of maribavir powder for oral suspension (Sequence D) on Day 7 and then followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Drug: Maribavir
Participants under fast will receive 200 mg of maribavir powder for oral suspension (Sequence F) on Day 1 followed by participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 4 followed by participants under fast will receive 100 mg of maribavir powder for oral suspension (Sequence E) on Day 7 and then followed by 50 mg of maribavir powder for oral suspension (Sequence D) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Drug: Maribavir
Participants feed with a high fat meal will receive 200 mg of maribavir powder for oral suspension (Sequence G) on Day 1 followed by participants under fast will receive 50 mg of maribavir powder for oral suspension (Sequence D) on Day 4 followed by 200 mg of maribavir powder for oral suspension (Sequence F) on Day 7 and then followed by 100 mg of maribavir powder for oral suspension (Sequence E) on Day 10 with a washout period of minimum 72 hours and maximum of 73 hours between Day 1, 4, 7 and 10. Doses to be evaluated in Part 2 may be adjusted based on relative bioavailability of the selected pediatric formulation (powder for oral suspension) to the Phase 3 tablet formulation observed in Part 1.
Drug: Maribavir
Participants in both part 1 and part 2 of the study will receive maribavir tablet or suspension orally depending upon the treatment sequence allocation for a total of 7 and 10 days respectively.
Also known as: TAK620, SHP620
Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
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.
Time frame: 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
Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma
tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported.
Time frame: 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
Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma
AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Time frame: 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
Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma
AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
Time frame: 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
Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma
t1/2 of maribavir in plasma was reported.
Time frame: 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
Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma
CL/F of maribavir in Plasma was reported.
Time frame: 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
Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma
Tlag of maribavir in plasma was reported.
Time frame: 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
Part 1: Number of Participants With Responses to Palatability Assessment 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.
Time frame: Up to Day 7
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
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.
Time frame: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE.
Time frame: From start of study drug administration up to follow-up (Day 17)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs
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.
Time frame: From start of study drug administration up to follow-up (Day 17)
This study was conducted at single site in United States of America from 25 October 2019 (first participant first visit) and 06 January 2020 (last participant last visit).
| Milestone | Maribavir |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Micrograms per milliliter (mcg/mL) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Part 1: Maximum Concentration (Cmax) Occurred at Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma | 10.7 ± 31.42 | 7.35 ± 46.92 | 6.84 ± 56.71 |
tmax defined as time of maximum observed concentration sampled during a dosing interval of maribavir in plasma were reported.
| Hour | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Part 1: Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Maribavir in Plasma | 1.00 (0.500 to 2.00) | 3.00 (1.00 to 4.00) | 2.00 (1.00 to 4.00) |
AUC0-last of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
| Hour*micrograms per milliliter (h*μg/mL) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Part 1: Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of Maribavir in Plasma | 50.1 ± 49.21 | 41.2 ± 55.09 | 39.1 ± 60.58 |
AUC0-Inf of maribavir in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) were reported.
| h*μg/mL | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Area Under the Curve Extrapolated to Infinity, Calculated Using the Observed Value of the Last Non-Zero Concentration (AUC0-Inf) of Maribavir in Plasma | 52.5 ± 49.72 | 44.5 ± 56.26 | 42.4 ± 60.69 |
t1/2 of maribavir in plasma was reported.
| Hour | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Part 1: Terminal Half-Life (t1/2) of Maribavir in Plasma | 4.04 (1.33 to 8.07) | 4.80 (1.90 to 11.6) | 5.95 (1.36 to 10.1) |
CL/F of maribavir in Plasma was reported.
| Liters per hour (L/h) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Part 1: Apparent Total Body Clearance Following Extravascular Administration (CL/F) of Maribavir in Plasma | 4.21 ± 1.99 | 5.13 ± 2.82 | 5.49 ± 3.29 |
Tlag of maribavir in plasma was reported.
| Hour | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Part 1: Delay Between the Time of Dosing and Time of Appearance of Plasma Concentration (Tlag) of Maribavir in Plasma | 0.00 (0.00 to 0.250) | 0.250 (0.00 to 0.500) | 0.250 (0.00 to 0.500) |
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.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| How this drug tasted to you?: Bitter | 2 | 14 | 14 |
| How this drug tasted to you?: Salty | 0 | 0 | 1 |
| How this drug tasted to you?: Sour | 0 | 1 | 0 |
| How this drug tasted to you?: Sweet | 0 | 0 | 0 |
| How this drug tasted to you?: Savory | 0 | 0 | 0 |
| How this drug tasted to you?: No taste | 16 | 4 | 5 |
| How strong was the taste?: Strong | 0 | 8 | 8 |
| How strong was the taste?: Medium | 1 | 6 | 3 |
| How strong was the taste?: Weak | 1 | 1 | 4 |
| How strong was the taste?: no taste | 16 | 4 | 5 |
| Did the drug have a rough or gritty texture?: No | 18 | 4 | 4 |
| Did the drug have a rough or gritty texture?: Yes | 0 | 15 | 16 |
| Was the drug easy to swallow?: No | 0 | 0 | 0 |
| Was the drug easy to swallow?: Yes | 18 | 19 | 20 |
| Overall taste & texture?: Agree | 18 | 10 | 13 |
| Overall taste & texture?: Neither agree/disagree | 0 | 5 | 4 |
| Overall taste & texture?: Disagree | 0 | 4 | 3 |
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.
| Participants | Maribavir |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 |
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.
| Participants | Maribavir |
|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs | 0 |
12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE.
| Participants | Maribavir |
|---|---|
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs | 0 |
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.
| Participants | Maribavir |
|---|---|
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs | 0 |
Collected over From start of study drug administration up to follow-up (Day 17). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maribavir | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Event | Maribavir |
|---|---|
| FlatulenceGastrointestinal disorders | 1/20 |
| Liver function test increasedInvestigations | 1/20 |
| HeadacheNervous system disorders | 1/20 |
Safety set 1 consisted of all participants who received at least 1 dose of maribavir in Part 1.
| Age, Continuous(Years) | Maribavir |
|---|---|
| Mean | 33.7 ± 8.90 |
| Sex: Female, Male(Participants) | Maribavir |
|---|---|
| Female | 12 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Maribavir |
|---|---|
| Hispanic or Latino | 17 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Maribavir |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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