Effect of PBI-4050 on the Pharmacokinetics of Midazolam in Heathy Adult Subjects

• Status: Completed
• Trial end date: 2018-08-22
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of PBI-4050 combined with midazolam in healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liminal BioSciences Ltd.; ProMetic Pharma SMT Limited
• Collaborator: Celerion
• Treatments: Midazolam

Criteria

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.