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

NCT ID: NCT03637049

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2018-08-22

Brief Summary

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

Detailed Description

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This is a Phase 1, single-center, open-label, 2-period, fixed sequence study to investigate the effect of multiple doses of PBI-4050 on the PK of midazolam, a cytochrome P450 (CYP) 3A substrate, in healthy adult men and healthy women of non-childbearing potential (WONCBP), and to determine the safety and tolerability of PBI-4050, when co-administered with midazolam.

On Day 1 of Period 1, subjects will receive a single oral dose of midazolam followed by PK sampling of midazolam and its metabolite 1-hydroxymidazolam (1-OH-midazolam). In Period 2, subjects will receive multiple daily doses of PBI-4050 for 5 consecutive days (Day 1 to Day 5) with a single oral dose of midazolam co-administered on Day 5. PK sampling for midazolam and 1-OH-midazolam will be collected for 24 hours following dosing on Day 5. PK sampling for PBI-4050 and its major metabolite will be collected at pre-dose on Days 3, 4, and 5.

There will be a washout period of at least 2 days between midazolam dose in Period 1 and the first PBI-4050 dose in Period 2.

Conditions

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Healthy

Keywords

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PBI-4050 drug-drug interaction CYP3A midazolam healthy subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PBI-4050 and midazolam

Midazolam 2 mg solution once (Period 1), PBI-4050 1200 mg (3 x 400 mg tablets) once per day for 5 days and midazolam 2 mg solution once on last day (Period 2).

Group Type EXPERIMENTAL

PBI-4050 and midazolam

Intervention Type DRUG

A single oral dose of midazolam (1 mL of 2mg/mL syrup) will be given to all subjects in Period 1 and on Day 5 of Period 2. 1200 mg of PBI-4050 (3 X 400 mg tablets) will be administered for 5 days (Day 1 to Day 5) of Period 2 and a single dose of midazolam (1 mL of 2mg/mL) on Day 5.

Interventions

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PBI-4050 and midazolam

A single oral dose of midazolam (1 mL of 2mg/mL syrup) will be given to all subjects in Period 1 and on Day 5 of Period 2. 1200 mg of PBI-4050 (3 X 400 mg tablets) will be administered for 5 days (Day 1 to Day 5) of Period 2 and a single dose of midazolam (1 mL of 2mg/mL) on Day 5.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celerion

INDUSTRY

Sponsor Role collaborator

Liminal BioSciences Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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CA25590

Identifier Type: OTHER

Identifier Source: secondary_id

PBI-4050-CT-9-16

Identifier Type: -

Identifier Source: org_study_id