ACTRN12624000718549
Completed
Phase 1
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 Pravastatin
CTI Clinical Trial and Consulting Services Australia Pty Ltd0 sites36 target enrollmentJune 11, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Phenylketonuria
- Sponsor
- CTI Clinical Trial and Consulting Services Australia Pty Ltd
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 1
Phase 1 Drug-Drug Interaction Study between TAK-272 and Itraconazole, Digoxin and MidazolamJPRN-jRCT2080222758TAKEDA PHARMACEUTICAL COMPANY LTD.34
Completed
Not Applicable
A Phase 1, Open-Label, Multicenter, Drug-Drug Interaction Study of TAK-788 and Midazolam, a Sensitive CYP3A Substrate, in Patients With Advanced Non*Small Cell Lung CancerNL-OMON49519Millenium Pharmaceuticals6
Unknown
Phase 3
An Open-label, Single-center, Drug-drug Interaction Study to Assess the Effect of SK-0403 on the Pharmacokinetics, Pharmacodynamics and Safety of Multiple Oral Administration of Metformin in Japanese Patients With Type 2 DiabetesType 2 diabetes mellitusJPRN-jRCT2080221200SANWA KAGAKU KENKYUSHO Co., Ltd.18
Unknown
Phase 3
An Open-label, Single-center, Drug-drug Interaction Study to Assess the Effect of SK-0403 on the Pharmacokinetics, Pharmacodynamics and Safety of Multiple Oral Administration of Miglitol in Japanese Patients With Type 2 DiabetesType 2 diabetes mellitusJPRN-jRCT2080221125SANWA KAGAKU KENKYUSHO Co., Ltd.18
Completed
Not Applicable
A phase 1, open-label, fixed-sequence, drug-drug interaction study of APX001 to evaluate the effects of CYP3A4 inhibition and pan-CYP induction in two parallel groups of healthy male and female subjectsFungal infectionsNL-OMON47992Amplyx Pharmaceuticals, Inc.36