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JNT-517 for Phenylketonuria

Phase 1
Recruiting
Research Sponsored by Jnana Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parts A, B, and C: Males and females 18 to 55 years of age
All Parts: Females of childbearing potential must agree to use 2 highly effective contraceptive methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up parts a and c: pre-dose to 72 hrs post-dose on day 1; part b: pre-dose to 24 hrs post-dose on days 1, 14 and pre-dose on days 3, 13; part d: pre-dose to 4 hrs post-dose on days 1, 14, 28
Awards & highlights

Study Summary

This trial studies safety, tolerability, & PK of oral JNT-517 in healthy participants & effect on PKU. It's 4 parts, each w/ screening, treatment & follow-up safety periods.

Who is the study for?
This trial is for healthy adults aged 18-55, and those with phenylketonuria (PKU) aged 18-65. Healthy participants must not smoke and have a BMI of 18-40 kg/m2. Women should agree to use two forms of contraception. PKU patients need a confirmed diagnosis and at least two plasma Phe levels >600 μM in the past year.Check my eligibility
What is being tested?
The study tests JNT-517's safety, tolerability, dosage effects, and impact on urinary Phe in healthy individuals and those with PKU across four parts: single & multiple dose studies, bioavailability comparison between tablet/suspension forms with food effect analysis in healthy volunteers, and a placebo-controlled test in PKU patients.See study design
What are the potential side effects?
Potential side effects are not detailed here but will be monitored throughout the trial phases focusing on any adverse reactions from taking JNT-517 or placebo as well as its overall tolerability during different dosing regimens.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I agree to use two effective birth control methods if I can have children.
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My BMI is between 18-40 and I weigh more than 110 lbs.
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I haven't smoked for at least 2 weeks and will not smoke during the study.
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I am generally healthy with no major medical issues.
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I have been diagnosed with PKU and my genetic test confirms it.
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I can sign the consent form and follow the study's procedures.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~parts a and c: pre-dose to 72 hrs post-dose on day 1; part b: pre-dose to 24 hrs post-dose on days 1, 14 and pre-dose on days 3, 13; part d: pre-dose to 4 hrs post-dose on days 1, 14, 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and parts a and c: pre-dose to 72 hrs post-dose on day 1; part b: pre-dose to 24 hrs post-dose on days 1, 14 and pre-dose on days 3, 13; part d: pre-dose to 4 hrs post-dose on days 1, 14, 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-emergent adverse events
Secondary outcome measures
Changes in urinary amino acid levels
Comparison of AUC of JNT-517 in fed and fasted states
Comparison of Cmax of JNT-517 in fed and fasted states
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C)Experimental Treatment2 Interventions
Single dose of JNT-517 tablet in a fed state, JNT-517 suspension, and JNT-517 tablet in a fasted state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives.
Group II: JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C)Experimental Treatment2 Interventions
Single dose of JNT-517 tablet in a fasted state, JNT-517 tablet in a fed state, and JNT-517 suspension in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives.
Group III: JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C)Experimental Treatment2 Interventions
Single dose of JNT-517 suspension, JNT-517 tablet in a fasted state, and JNT-517 tablet in a fed state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives.
Group IV: JNT-517 SAD (Part A)Experimental Treatment2 Interventions
Single dose of JNT-517 or placebo in fasted state.
Group V: JNT-517 PKU (Part D)Experimental Treatment2 Interventions
JNT-517 or placebo daily for 4 weeks. Dose is based on data from Parts A, B, and C.
Group VI: JNT-517 MAD (Part B)Experimental Treatment2 Interventions
JNT-517 or placebo once or twice daily for 14 days, with first daily dose given after an overnight fast.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Tablet
2016
Completed Phase 3
~3690
Placebo Suspension
2014
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Jnana TherapeuticsLead Sponsor

Media Library

JNT-517 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05781399 — Phase 1
Phenylketonuria Research Study Groups: JNT-517 SAD (Part A), JNT-517 MAD (Part B), JNT-517 PKU (Part D), JNT-517 Tablet Fed Then Suspension Then Tablet Fasted (Part C), JNT-517 Suspension Then Tablet Fasted Then Tablet Fed (Part C), JNT-517 Tablet Fasted Then Tablet Fed Then Suspension (Part C)
Phenylketonuria Clinical Trial 2023: JNT-517 Highlights & Side Effects. Trial Name: NCT05781399 — Phase 1
JNT-517 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05781399 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to join this experiment?

"Eligibility criteria for this research necessitates that participants have phenylketonuria and span the ages of 18 to 65. As of now, 112 individuals are being enrolled into this clinical trial."

Answered by AI

Are individuals being accepted into this clinical experiment at present?

"Clinicaltrials.gov displays that this clinical trial is currently seeking participants, with its original post date being October 31st 2022 and the latest update occurring on May 30th 2023."

Answered by AI

What is the current enrollment size of this research endeavor?

"Affirmative. According to the information found on clinicaltrials.gov, this examination is in the process of recruiting volunteers and was first published on October 31st 2022. As of May 30th 2023, there are 112 individuals sought from 2 clinics."

Answered by AI

Is this research endeavor open to those aged 55 and above?

"This study has a specific age range requirement of between 18 to 65 years old. Separately, there are 12 studies for those under the age of consent and another dozen trials available for people over the age of 65."

Answered by AI

Has the FDA granted authorization to JNT-517 SAD (Part A)?

"The safety of JNT-517 SAD (Part A) was assessed as a 1 on Power's scale due to the relative scarcity of data available about its efficacy and security."

Answered by AI
~36 spots leftby Dec 2024