A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on Maribavir (TAK-620) Pharmacokinetics in Healthy Adult Participants
Overview
- Phase
- Phase 1
- Intervention
- Maribavir
- Conditions
- Healthy Volunteers
- Sponsor
- Takeda
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The main goals of this study are: 1) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a low-fat/low-calorie meal relative to administration under fasting conditions. 2) To assess the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a high-fat/high calorie meal relative to administration under fasting conditions.
A single dose of 400 mg maribavir (commercial [marketed] tablet formulation) will be administered orally under 3 different feeding conditions:
- Fasting (Treatment A),
- Fed following a low-fat/low-calorie meal (Treatment B), and
- Fed following a high fat/high-calorie meal (Treatment C).
There will be a washout period of a minimum of 72 hours between each single dose of investigational drug (ID) administration on Day 1 in each treatment cycle of 3 days.
Pharmacokinetic samples will be collected at pre-dose and up to 36 hours post-dose in each treatment period.
Safety and tolerability will be assessed throughout the study by Treatment Emergent Adverse Events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sequence 1: Treatment A + Treatment B + Treatment C
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet, on Day 1 of Period 2. administered with a low fat/low calorie meal (Treatment B), and further followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of minimum of 72 hours between each ID dosing.
Intervention: Maribavir
Sequence 2: Treatment A + Treatment C + Treatment B
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 under fasting condition (Treatment A), followed by maribavir single 400 mg tablet on Day 1 of Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a low fat/low calorie meal (Treatment B). There will be a washout period of minimum of 72 hours between each ID dosing.
Intervention: Maribavir
Sequence 3: Treatment B + Treatment A + Treatment C
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of minimum of 72 hours between each ID dosing.
Intervention: Maribavir
Sequence 4: Treatment B + Treatment C + Treatment A
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a low fat/low calorie meal (Treatment B), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 administered with a high fat/high calorie meal (Treatment C), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 under fasting condition (Treatment A). There will be a washout period of minimum of 72 hours between each ID dosing.
Intervention: Maribavir
Sequence 5: Treatment C + Treatment A + Treatment B
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 under fasting condition (Treatment A), and followed by maribavir single 400 mg tablet, on Day 1 of Period 3 administered with a low fat/low calorie meal (Treatment B). There will be a washout period of minimum of 72 hours between each ID dosing.
Intervention: Maribavir
Sequence 6: Treatment C + Treatment B + Treatment A
Participants will receive maribavir single 400 mg tablet, on Day 1 of Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 400 mg tablet, on Day 1 of Period 2 administered with a low fat/low calorie meal (Treatment B), and followed by maribavir single 400 mg tablet on Day 1 of Period 3 under fasting condition (Treatment A). There will be a washout period of minimum of 72 hours between each ID dosing.
Intervention: Maribavir
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of Maribavir
Time Frame: Day 1: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dose
AUC0-infinity of maribavir in plasma was reported using the non-compartmental analysis.
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: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dose
AUClast of maribavir in plasma was reported using the non-compartmental analysis.
Maximum Observed Plasma Concentration (Cmax) of Maribavir
Time Frame: Day 1: Pre dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 36-hours post-dose
Cmax of maribavir in plasma was reported using the non-compartmental analysis.
Secondary Outcomes
- Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs(From start of study drug administration to follow-up (up to Day 18))
- Number of Participants Based on Severity of TEAEs(From start of study drug administration to follow-up (up to Day 18))
- Number of Participants Based on Causality of TEAEs(From start of study drug administration to follow-up (up to Day 18))