A Phase 1, Three-Part Open-Label Drug-Drug Interaction Study in Healthy participants to Determine the Effects of Itraconazole on the Pharmacokinetics of JNT-517 (Victim) and the Effects of JNT-517 (Perpetrator) on the Pharmacokinetics of Midazolam and Pravastati
- Conditions
- PhenylketonuriaMetabolic and Endocrine - Metabolic disordersHuman Genetics and Inherited Disorders - Other human genetics and inherited disorders
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1. Males and females 18 to 55 years of age, inclusive.
2. Medically healthy with no clinically significant medical history, physical examination, laboratory results, vital signs, or ECGs.
3. Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg (110 lbs).
4. Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the study.
5. Participants with psychiatric illness must be well-controlled for the last 6 months prior to the Screening visit and if on medication, on stable medications for the last 3 months.
6. Capable of giving signed informed consent and able to comply with study procedures
1. Any acute or chronic medical condition that would prevent the participant from complying with
the procedures or place the participant at risk if they participate in the study.
2. Positive for hepatitis B or C or human immunodeficiency virus.
3. Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer.
4. Any history of liver disease
Any surgical or medical conditions that may affect study drug absorption, distribution,
metabolism, or excretion.
6. Creatinine clearance <90 mL/min by the Chronic Kidney Disease Epidemiology Collaboration
(CKD-EPI) creatine equation.
7. Received another investigational drug within 30 days or, if known, 5 half-lives of the
investigational drug (whichever is longer).
8. Alcohol consumption within 5 days of Check in and/or unwilling to abstain during the study.
9. Has consumed herbal preparations/medications, including but not limited to St. John's wort, kava,
ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, or ginseng,
within 7 days prior to study drug dosing.
10. Intake of nutritional supplements, juice, other foods or beverages that may affect the various drug
metabolizing enzymes and transporters (eg, alcohol, grapefruit, starfruit, Seville oranges, or their
products) are not permitted for 7 days before dosing and throughout the study.
11. Smoker (defined as an individual who has used nicotine-containing products, including cigarettes
and e-cigarettes) within the last 2 weeks prior to dosing and a positive cotinine test on Day –1.
12. Consumption of caffeinated beverages or food within 72 hours prior to Check-in.
13. Use or intend to use any prescription medications/products within 14 days prior to dosing, unless
deemed acceptable by the Investigator (or designee), or use or intend to use any nonprescription
medications/products including vitamins and minerals within 7 days prior to Check in, unless
deemed acceptable by the Investigator (or designee).
14. Use or intend to use slow release medications/products considered to still be active within 14
days prior to Check in, unless deemed acceptable by the Investigator (or designee).
15. Use of any medications that are inhibitors or inducers of cytochrome P450 (CYP)3A4 or
inhibitors of the transporter P-glycoprotein (P-gp) within 4 weeks prior to randomization and
unwilling and/or unable to avoid these medications throughout the treatment duration.
16. Use of any medication that is a substrate of CYP3A4, or a substrate of the transporters P-gp,
breast cancer resistance protein (BCRP), organic anion transporter 3 (OAT3), multidrug and toxin
extrusion (MATE)1, or MATE2-K within 4 weeks prior to randomization and unwilling and/or
unable to avoid these medications throughout the treatment duration.
17. History of drug/alcohol abuse in the last year.
18. Positive drug screen.
19. Unable to tolerate oral medication.
20. Allergy to JNT-517 or any component of the investigational product.
21. Allergy to itraconazole (Part A), midazolam (Part B), or pravastatin (Part C)
22. Previous exposure to JNT-517 in another clinical trial
23. Received >50 mL of blood or plasma within 30 days of Screening or >500 mL of blood or plasma
within 60 days of Screening.
24. Blood donation of >500 mL within 56 days prior to Screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method