Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541678
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-Label Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron 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 see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants The information from this study may inform how danuglipron will be used in the future with medicines like cyclosporine and itraconazole
Detailed Description:
This study is seeking healthy participants who
are aged 18 years of age or older
are confirmed to be healthy by some medical tests
both men and women can participate Women who can produce a baby must agree to use a highly effective method of birth control
have body mass index BMI of 16 to 32 kilograms per meter squared
a total body weight of more than 50 kilograms
Participants will receive danuglipron tablet by mouth on Day 1 Then on Day 4 participants will take cyclosporine capsules and danuglipron tablet by mouth at the same time From Day 7 of the study participants will take itraconazole solution by mouth once a day until Day 12 On Day 10 of the study danuglipron tablet will also be taken with itraconazole at the same time
The total planned time of participation is about 10 weeks The study consists of
screening period of up to 28 days before taking sisunatovir 13 days of staying in the study clinic a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time
are aged 18 years of age or older
are confirmed to be healthy by some medical tests
both men and women can participate Women who can produce a baby must agree to use a highly effective method of birth control
have body mass index BMI of 16 to 32 kilograms per meter squared
a total body weight of more than 50 kilograms
Participants will receive danuglipron tablet by mouth on Day 1 Then on Day 4 participants will take cyclosporine capsules and danuglipron tablet by mouth at the same time From Day 7 of the study participants will take itraconazole solution by mouth once a day until Day 12 On Day 10 of the study danuglipron tablet will also be taken with itraconazole at the same time
The total planned time of participation is about 10 weeks The study consists of
screening period of up to 28 days before taking sisunatovir 13 days of staying in the study clinic a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time
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