Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389955
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-04-22
Brief Title:
Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Phase 1 Randomized Study in Healthy Volunteers to Assess Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study comprised of 2 parts Part A and Part B Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70 of the capsule formulation
Detailed Description:
Part A is a randomized single-dose 4-period 4-way cross-over study to evaluate the effect of food on the TP 3654 capsule and assess the relative bioavailability of the TP-3654 capsule versus tablet formulations Following a screening period of up to 28 days eligible participants will be admitted to the clinical research unit CRU on Day -1 Participants will fast overnight from Day -1 to Day 1 On Day 1 participants will be randomly assigned to a treatment sequence and they will receive TP-3654 per their assigned sequence
Part B is a randomized single-dose 3-period 3-way cross-over study to evaluate the effect of food on the PK of the TP-3654 tablet formulation Following a screening period of up to 28 days eligible participants will be admitted to the CRU on Day -1 As with Part A participants will fast overnight from Day -1 to Day 1 On Day 1 they will be randomly assigned to a treatment sequence and they will receive TP-3654 per their assigned sequence
Part B is a randomized single-dose 3-period 3-way cross-over study to evaluate the effect of food on the PK of the TP-3654 tablet formulation Following a screening period of up to 28 days eligible participants will be admitted to the CRU on Day -1 As with Part A participants will fast overnight from Day -1 to Day 1 On Day 1 they will be randomly assigned to a treatment sequence and they will receive TP-3654 per their assigned sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None