Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637514
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
A Phase 2 Study of JNT-517 in Adolescent Participants with Phenylketonuria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of JNT-517 in Adolescent Participants with Phenylketonuria
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 goal of this Phase 2 randomized study is to assess the safety tolerability and pharmacokinetics PK of oral JNT-517 in adolescents 12 to less than 18 years of age with PKU Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment Participants will have a 4 in 5 or 80 chance of receiving JNT-517 The study will last for up to 63 days including a Screening period Treatment period and Follow-up period for safety
Participants will
Take 75 mg JNT-517 or a placebo BID 2x per day for 28 days
Visit the clinic or have a mobile health nurse visit your home for checkups and tests
Collect urine sample at home and bring to clinic on specified days
Keep a food diary 3 days before each study visit
Participants will
Take 75 mg JNT-517 or a placebo BID 2x per day for 28 days
Visit the clinic or have a mobile health nurse visit your home for checkups and tests
Collect urine sample at home and bring to clinic on specified days
Keep a food diary 3 days before each study visit
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