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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

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ClinicalTrials.gov Identifier: NCT04497883
Recruitment Status : Completed
First Posted : August 4, 2020
Results First Posted : February 8, 2022
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Maribavir (400 mg) Drug: Maribavir (200 mg) Drug: Maribavir (800 mg) Phase 1

Detailed Description:

The study will be conducted in two cohorts, Cohort A and Cohort B. Cohort A consists of 12 participants of Japanese Descent. Cohort B consists of 12 non-Hispanic, Caucasian participants.

For Japanese participants there will be three treatment periods. In Treatment Period 1, they will receive maribavir as a single 400 mg oral dose. In Treatment Periods 2 and 3, all Japanese participants will receive maribavir as a single oral dose of either 200 mg or 800 mg, depending upon randomization assignment. For the non-Hispanic, Caucasian group there will be only one treatment period and they will receive maribavir as a single 400 mg oral dose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Subjects Compared With Matched, Healthy, Non-Hispanic, Caucasian Subjects and to Assess Dose-Proportionality of 3 Doses of Maribavir in the Japanese Subjects
Actual Study Start Date : August 7, 2020
Actual Primary Completion Date : November 12, 2020
Actual Study Completion Date : November 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A: Non-Hispanic, Caucasian
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)
Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
Other Names:
  • SHP620
  • TAK-620

Experimental: Cohort B: Japanese Descent
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)
Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
Other Names:
  • SHP620
  • TAK-620

Drug: Maribavir (200 mg)
Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
Other Names:
  • SHP620
  • TAK-620

Drug: Maribavir (800 mg)
Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
Other Names:
  • SHP620
  • TAK-620




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Maribavir [ Time Frame: 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 ]
    Cmax of maribavir in plasma were reported.

  2. Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir [ Time Frame: 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 ]
    AUClast of maribavir in plasma were reported.

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir [ Time Frame: 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 ]
    AUC(0-infinity) of maribavir in plasma were reported.


Secondary Outcome Measures :
  1. Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants [ Time Frame: 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 was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.

  2. Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants [ Time Frame: 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 was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.

  3. Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants [ Time Frame: 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 was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: From start of study drug administration to follow-up (up to Day 23) ]
    An 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 investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).
  • Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches.
  • Current use of any prescription medication within 30 days of the first dose of IP. Current use of any over the counter medication within 14 days of the first dose of IP.
  • Ingestion of known cytochrome P450 (CYP) 3A modulators within 7 days of Day 1, period 1
  • History of active or chronic oral/nasal cavity infections, gastroesophageal reflux, asthma treatment with albuterol, zinc supplementation.
  • Participants with dry mouth syndrome or burning mouth syndrome or menopausal women suffering from dysgeusia.
  • Participants who have acute gastrointestinal (GI) symptoms at screening or admission (e.g. nausea, vomiting, diarrhea, and heartburn).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497883


Locations
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United States, Nevada
PPD Development, LP
Las Vegas, Nevada, United States, 89113
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire
  Study Documents (Full-Text)

Documents provided by Takeda ( Shire ):
Study Protocol  [PDF] July 8, 2020
Statistical Analysis Plan  [PDF] August 6, 2020

Additional Information:
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT04497883    
Other Study ID Numbers: TAK-620-1020
First Posted: August 4, 2020    Key Record Dates
Results First Posted: February 8, 2022
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Maribavir
Antiviral Agents
Anti-Infective Agents