A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants

NCT04497883 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-620-1020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability of maribavir administered as a single oral dose in healthy, adult participants of Japanese descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this study will assess the dose-proportionality of PK of maribavir in healthy, adult participants of Japanese descent.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Maribavir

  Cmax of maribavir in plasma were reported.

  Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir

  AUClast of maribavir in plasma were reported.

  Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir

  AUC(0-infinity) of maribavir in plasma were reported.

  Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

Secondary Outcomes (4)

• Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants

  Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

• Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants

  Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

• Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants

  Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

  From start of study drug administration to follow-up (up to Day 23)

Study Arms (2)

Cohort A: Non-Hispanic, Caucasian

EXPERIMENTAL

Non-Hispanic, Caucasian group participants will receive 400 milligram (mg) maribavir tablets orally once on Day 1 during treatment period 1.

Drug: Maribavir (400 mg)

Cohort B: Japanese Descent

EXPERIMENTAL

Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1 followed by 200 mg or 800 mg maribavir tablets orally once on Day 1 during treatment period 2 followed by 800 mg or 200 mg maribavir tablets orally once on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours will be maintained between treatment period 1, 2, and 3.

Drug: Maribavir (400 mg); Drug: Maribavir (200 mg); Drug: Maribavir (800 mg)

Interventions

Maribavir (400 mg) DRUG

Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.

Also known as: SHP620, TAK-620

Cohort A: Non-Hispanic, Caucasian; Cohort B: Japanese Descent

Maribavir (200 mg) DRUG

Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.

Also known as: SHP620, TAK-620

Cohort B: Japanese Descent

Maribavir (800 mg) DRUG

Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.

Also known as: SHP620, TAK-620

Cohort B: Japanese Descent

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• An understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Ability to voluntarily provide written informed consent/assent as applicable to participate in the study.
• Healthy 18 to 55 years old participants of Japanese descent and non-Hispanic Caucasian origin.
• Healthy participants of Japanese descent must have been born in Japan and must not have lived outside of Japan for greater than (\>) 10 years; both parents and all 4 grandparents must be of Japanese origin. Healthy, non-Hispanic, Caucasian participants must have both parents and all 4 grandparents of non-Hispanic, Caucasian origin.
• Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
• Hemoglobin for males greater than or equal to (\>=) 135.0 gram per liter (g/L) and females \>= 120.0 g/L at screening and on Day -1.
• Body mass index (BMI) between 18.5 and 28.0 kilogram per square meter (kg/m\^2) inclusive with a body weight \> 45 kilograms (kg) (99 pounds \[lbs\]).
• Ability to swallow a dose of investigational product (IP).

You may not qualify if:

• History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current recurrent disease.
• Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
• Known or suspected intolerance or hypersensitivity to maribavir, closely-related compounds, or any of the stated ingredients.
• Significant illness, as judged by the investigator, within 2 weeks of the first dose of IP.
• Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to receiving the first dose of IP.
• Have taken another IP within 30 days or five half-lives of that IP, whichever is greater, prior to the first dose of maribavir.
• Have been enrolled in a clinical study (including vaccine studies) within 30 days prior to the first dose of IP that, in the investigator's opinion, may impact this study.
• Have had any substantial changes in eating habits within 30 days prior to the first dose of IP, as assessed by the investigator.
• Confirmed systolic blood pressure \> 139 millimeter of mercury (mmHg) or less than (\<) 89 mmHg, and diastolic blood pressure \> 89 mmHg or \< 49 mmHg.
• Twelve-lead ECG demonstrating QTc \> 450 milliseconds (msec).
• Known history of alcohol or other substance abuse, including synthetic cannabinoids within the last year.
• Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.
• A positive urine test for drugs of abuse, alcohol, or cotinine at screening or on Day -1.
• A positive human immunodeficiency virus (HIV), hepatitis B surface antibody (HBsAg), or hepatitis C virus (HCV) antibody screen.
• Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch).

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

PPD Development, LP

Las Vegas, Nevada, 89113, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

maribavir

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@takeda.com

+1 866 842 5335

Study Officials

• Study Director

  Shire

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 4, 2020
• Study Start: August 7, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: September 11, 2025
• Results First Posted: February 8, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)