A Study of Maribavir Pediatric Formulation in Healthy Adult Participants

NCT05918822 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-620-1024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part. The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in the digestive tract compared to commercial tablet formulation and to check how a high-fat, high-calorie meal affects absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension. The main aim of Part 2 of this study is to assess the stomach acid reducing effect of multiple doses of rabeprazole on absorption, distribution, and elimination of maribavir pediatric formulation given orally as water suspension. Each participant will stay in the study clinic from the day before the first treatment until the day after the last treatment.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Maribavir

  Cmax was defined as maximum observed concentration of maribavir in plasma.

  Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose

• Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Maribavir

  AUClast was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration of maribavir in plasma.

  Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose

• Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir

  AUC0-infinity was defined as the area under the plasma concentration-time curve from time 0 to infinity of maribavir in plasma.

  Part 1 Day 1 and Part 2 Treatment D Day 1 and Treatment E Day 5: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours post-dose

Secondary Outcomes (3)

• Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

  Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

• Number of Participants Based on Severity of TEAEs

  Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

• Number of Participants Based on Causality of TEAEs

  Parts 1 and 2: From start of study drug administration up to follow-up (Day 16)

Study Arms (8)

Part 1, Sequence 1: Treatment A + Treatment B + Treatment C

EXPERIMENTAL

Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment.

Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 1, Sequence 2: Treatment A + Treatment C + Treatment B

EXPERIMENTAL

Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment.

Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 1, Sequence 3: Treatment B + Treatment A + Treatment C

EXPERIMENTAL

Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment.

Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 1, Sequence 4: Treatment B + Treatment C + Treatment A

EXPERIMENTAL

Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment.

Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 1, Sequence 5: Treatment C + Treatment A + Treatment B

EXPERIMENTAL

Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment.

Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A

EXPERIMENTAL

Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition as (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment.

Drug: Maribavir Commercial Tablet Formulation; Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 2: Treatment D: maribavir 200 mg

EXPERIMENTAL

Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment D).

Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation

Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg

EXPERIMENTAL

Participants will receive rabeprazole single 20 mg tablet, once daily on Days 1 to 5 of Treatment Period 2 under fasting condition followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose, 2 hours after rabeprazole dosing on morning of Day 5 of Treatment Period 2 under fasting condition (Treatment E). There will be a washout period of a minimum of 72 hours between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2.

Drug: Maribavir Pediatric Powder-for-oral Suspension Formulation; Drug: Rabeprazole

Interventions

Maribavir Commercial Tablet Formulation DRUG

Maribavir commercial tablet.

Also known as: TAK-620

Part 1, Sequence 1: Treatment A + Treatment B + Treatment C; Part 1, Sequence 2: Treatment A + Treatment C + Treatment B; Part 1, Sequence 3: Treatment B + Treatment A + Treatment C; Part 1, Sequence 4: Treatment B + Treatment C + Treatment A; Part 1, Sequence 5: Treatment C + Treatment A + Treatment B; Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A

Maribavir Pediatric Powder-for-oral Suspension Formulation DRUG

Maribavir pediatric powder-for-oral suspension.

Also known as: TAK-620

Part 1, Sequence 1: Treatment A + Treatment B + Treatment C; Part 1, Sequence 2: Treatment A + Treatment C + Treatment B; Part 1, Sequence 3: Treatment B + Treatment A + Treatment C; Part 1, Sequence 4: Treatment B + Treatment C + Treatment A; Part 1, Sequence 5: Treatment C + Treatment A + Treatment B; Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A; Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg; Part 2: Treatment D: maribavir 200 mg

Rabeprazole DRUG

Rabeprazole tablet.

Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg

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 and to voluntarily sign (personally or via a legally authorized representative) informed consent form to participate in the study.
• Age 18 to 55 years, inclusive at the time of consent, at the screening visit.
• Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol or female of non-childbearing potential.
• Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), inclusive with a body weight greater than (\>) 50 kilograms (kg) (110 pounds \[lbs\]), at the screening visit.
• Healthy as determined by the Investigator or designee on the basis of screening evaluations and medical history.
• Hemoglobin for males greater than or equal to (\>=) 135.0 gram per liter (g/L) and females \>=120.0 g/L, at the screening visit and on Day -1 of Treatment Period 1.
• Ability to swallow a dose of maribavir or rabeprazole.

You may not qualify if:

• History or presence of gastritis, gastrointestinal (GI) tract disorder, hepatic disorder or cholecystectomy, history of treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in the opinion of the investigator or designee, may affect the absorption, distribution, metabolism, or elimination of the study drugs.
• History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current recurrent disease that could affect the action, absorption, or disposition of the study drugs, or clinical or laboratory assessments.
• 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 study drugs or procedures.
• Known or suspected intolerance or hypersensitivity to maribavir or rabeprazole (Part 2 only), closely related compounds, or any of the stated ingredients and excipients.
• Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose of the investigational drug (ID).
• Has diarrhea within 4 hours of the first dose of the ID.
• Donation of blood or blood products (example, plasma or platelets) within 60 days prior to receiving the first dose of the ID.
• Within 30 days prior to the first dose of the ID:
• Have used any investigational product (if elimination half-life is less than \[\<\] 6 days, otherwise 5 half-lives).
• Have been enrolled in a clinical study (including vaccine studies) that, in the Investigator or designee's opinion, may impact this Takeda-sponsored study.
• Have had any substantial changes in eating habits, as assessed by the Investigator or designee.
• Systolic blood pressure \>140 millimeters of mercury (mmHg) or \<90 mmHg, and/or diastolic blood pressure \>90 mmHg or \<50 mmHg, at the screening visit.
• Corrected QT interval (QTc) \>450 millisecond (msec) at the screening visit. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the participant's eligibility.
• Known history of alcohol or other substance abuse within the last year.
• Male participants who consume more than 21 units of alcohol per week or three units per day. Female participants who consume more than 14 units of alcohol per week or two units per day (one alcohol unit = one beer or one wine \[5 ounces \[oz\]/150 milliliter \[mL\]\] or one liquor \[1.5 oz/40 mL\] or 0.75 oz alcohol).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

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

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: June 16, 2023
• First Posted: June 26, 2023
• Study Start: July 25, 2023
• Primary Completion: August 25, 2023
• Study Completion: September 1, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, 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.

Locations

US (1)