Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646042
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
A Study to Learn If the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine Ibuzatrelvir in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE 1 OPEN-LABEL FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF IBUZATRELVIR IN HEALTHY ADULT PARTICIPANTS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to estimate the effect of carbamazepine a strong CYP3A4 inducer on the pharmacokinetics PK of ibuzatrelvir in healthy participants
This study is seeking participants who
are male or female that are not of childbearing potential of 18 years of age or older
are examined to be healthy
The study will consist of two treatments 1 a single oral dose of ibuzatrelvir 600 mg alone in Period 1 and 2 carbamazepine q12h BID titrated from 100 mg to 300 mg over 15 days with a single ibuzatrelvir 600 mg dose coadministered on day 15 in Period 2 All treatments will be taken by mouth
All participants will remain in the study clinic for 18 days for safety review laboratory collections and to collect samples for PK
All participants selected in the study will be required to go through a screening period up to 28 days A screening period is the time during which a few participants are examined to see whether they are fit for the study During this period the participants medical history and past and current medications will be reviewed A series of tests will also be performed to see if they are good to be selected for the study If the participant meets all required criteria and are interested in continuing the participant will be brought into the study clinic to stay overnight for 18 days About 28 to 35 days after discharge following the final treatment the participant will be contacted for a follow up visit either in person or by telephone This is to check up on how the participant is doing and to conclude the study
This study is seeking participants who
are male or female that are not of childbearing potential of 18 years of age or older
are examined to be healthy
The study will consist of two treatments 1 a single oral dose of ibuzatrelvir 600 mg alone in Period 1 and 2 carbamazepine q12h BID titrated from 100 mg to 300 mg over 15 days with a single ibuzatrelvir 600 mg dose coadministered on day 15 in Period 2 All treatments will be taken by mouth
All participants will remain in the study clinic for 18 days for safety review laboratory collections and to collect samples for PK
All participants selected in the study will be required to go through a screening period up to 28 days A screening period is the time during which a few participants are examined to see whether they are fit for the study During this period the participants medical history and past and current medications will be reviewed A series of tests will also be performed to see if they are good to be selected for the study If the participant meets all required criteria and are interested in continuing the participant will be brought into the study clinic to stay overnight for 18 days About 28 to 35 days after discharge following the final treatment the participant will be contacted for a follow up visit either in person or by telephone This is to check up on how the participant is doing and to conclude the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None