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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT03637049

Run by

Liminal BioSciences Ltd.

People needed

22

Starts

2018-07-17

Expected to finish

2018-08-22

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females (WONCBP only).
• Age 18-65 years.
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
• Generally good health.
• Males willing to use appropriate contraception.

You may not qualify if…

• Significant medical history or physical findings.
• History or presence of drug allergy or hypersensitivity to treatment ingredients.
• Gastrointestinal surgery.
• Pregnant or lactating.
• Positive urine drug or alcohol screen.
• Abnormal heart rate or blood pressure.
• 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.
• Has been on a diet incompatible with the on-study diet.
• Recent blood donation or significant blood loss.
• Recent blood received.
• Participation in another clinical study within 30 days prior to the first.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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