Healthy Clinical Trial
Official title:
A Phase 1, Drug-Drug Interaction Study to Evaluate the Effect of PBI-4050 on the Pharmacokinetics of Midazolam, a Sensitive Cytochrome P450 3A Substrate, in Healthy Adult Subjects
Verified date | December 2020 |
Source | Liminal BioSciences Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of PBI-4050 combined with midazolam in healthy adult subjects.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 22, 2018 |
Est. primary completion date | August 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Males or females (WONCBP only). 2. Age 18-65 years. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing. 4. Body mass index (BMI) = 18.0 and = 32.0 kg/m2 at screening. 5. Generally good health. 6. Males willing to use appropriate contraception. Exclusion Criteria: 1. Significant medical history or physical findings. 2. History or presence of drug allergy or hypersensitivity to treatment ingredients. 3. Gastrointestinal surgery. 4. Pregnant or lactating. 5. Positive urine drug or alcohol screen. 6. Abnormal heart rate or blood pressure. 7. Prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety. • Receiving drugs known as significant inducers of CYP2C9, CYP3A4, CYP2C8 and/or CYP1A2 enzymes and/or P-glycoprotein, including St. John's Wort, for 28 days prior to the first dosing and throughout the study. 8. Has been on a diet incompatible with the on-study diet. 9. Recent blood donation or significant blood loss. 10. Recent blood received. 11. Participation in another clinical study within 30 days prior to the first. |
Country | Name | City | State |
---|---|---|---|
United States | Celerion | Tempe | Arizona |
Lead Sponsor | Collaborator |
---|---|
Liminal BioSciences Ltd. | Celerion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in area under the concentration-time curve (AUC0-t) for midazolam and 1-OH-midazolam in presence of PBI-4050 | AUC0-t (AUC from time 0 to last observed non-zero concentration) of midazolam and 1-OH-midazolam assessed on Day 1 (Period 1) and Day 5 (Period 2) | PK sampling at pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose on Day 1 in Period 1 and on Day 5 in Period 2 | |
Primary | Change in area under the concentration-time curve (AUC0-inf) for midazolam and 1-OH-midazolam in presence of PBI-4050 | AUC0-inf (AUC from time 0 extrapolated to infinity) of midazolam and 1-OH-midazolam assessed on Day 1 (Period 1) and Day 5 (Period 2) | PK sampling at pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose on Day 1 in Period 1 and on Day 5 in Period 2 | |
Primary | Change in maximum plasma concentration (Cmax) for midazolam and 1-OH-midazolam in presence of PBI-4050 | Cmax of midazolam and 1-OH-midazolam assessed on Day 1(Period 1) and Day 5 (Period 2) | PK sampling at pre-dose; and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose on Day 1 in Period 1 and on Day 5 in Period 2 | |
Primary | Change in concentration observed at the end of the dosing interval (Ctrough) for plasma PBI-4050 and its major metabolite | Ctrough is the concentration observed at the end of the dosing interval in Period 2. | PK sampling for PBI-4050 and its metabolite done at pre-dose on Days 3, 4, and 5 of Peiod 2 | |
Secondary | Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of subjects that experience Adverse Events (AEs). | 10 days |
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