CompletedPhase 1ACTRN12617000579392

A drug interaction study of DUR-928 and Midozolam

Drug Interaction Study to Evaluate the Effect of DUR-928 on the Pharmacokinetics of a Single Oral Dose of Midazolam in healthy participants.

Sponsor

INC Research

Enrollment

18 participants

Start Date

Jun 2, 2017

Study Type

Interventional

Conditions

Liver Disease

Summary

This research project is being conducted to look at the pharmacokinetics of both DUR-928 and Midazolam; this is done by measuring the amount of DUR-928 and Midazolam in the blood at different times throughout the dosing periods. Data from this study will allow us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream) and it will allow us to determine the impact of DUR-928 on how Midazolam is handled by the body.

Eligibility

Sex: Both males and femalesMin Age: 19 YearssMax Age: 55 Yearss

Inclusion Criteria6

Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening.
Weight at least 50kg and BMI between 18.0 kg/m2 and 30.0 kg/m2, inclusive.
Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed.
Female subjects must be of non-childbearing potential.
Willing and be able to be admitted to the clinical study unit for 9 nights and 9 days.
Able to abstain from alcohol and tobacco use during the trial.

Exclusion Criteria8

Significant blood loss or donated blood in the 30 days prior to study participation.
Participation in an investigational drug study within 30 days prior to dosing.
History of drug or alcohol abuse.
Use of any medications, including OTC and herbal or nutritional supplements within 2 weeks prior to study drug dosing, and for the study duration.
Use of grapefruit or grapefruit juice, apple or orange juice, vegetables from mustard green family (e.g. kale, watercress, collard greens, brussels sprouts, mustard) and charbroiled (grilled) meats within 1 week prior to study drug dosing, and for the study duration.
Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.
Clinically significant abnormalities.
Tobacco users who have used tobacco within the last 30 days prior to screening

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Interventions

The proposed study is an open label, single sequence, dosing study in 18 healthy male and female subjects, to obtain 15 evaluable subjects. Subjects will be screened to determine eligibility within 1

The proposed study is an open label, single sequence, dosing study in 18 healthy male and female subjects, to obtain 15 evaluable subjects. Subjects will be screened to determine eligibility within 14 days prior to dosing. Subjects will be admitted to the clinical unit on Day -1 for baseline assessments. On Day 1, subjects will receive an oral solution of midazolam 3mg. On Days 3, 4 and 5, subjects will receive an oral suspension of DUR-928 50 mg daily. On Day 6, subjects will receive an oral solution of midazolam 3mg as well as an oral suspension of DUR-928 50mg. On Day 8 subjects will receive DUR-928 (150 mg) as intravenous infusion over 2 hours immediately followed by an oral solution of midazolam 3 mg. All study treatments will be administered after an overnight fast of at least 10 hours. Subjects will continue to fast for 4 hours after the study drug administration. During fasting no fluids will be allowed except water; however water will not be allowed from 1 hour before dosing to 1 hour after dosing (except for 240 mL of water required to swallow DUR-928 or midazolam). Subjects will be confined in the study unit from Day -1 through Day 9 procedures and return to the clinic on Day 14 for trial completion procedures. DUR-928 oral dose: 50 mg of DUR-928 drug substance powder in a 60 cc wide mouth, amber glass bottle with a child-resistant screw cap. At the time of administration, 60 mL of a commercially available flavored, sugar-free, vehicle (ORA-Blend SF) is added to the bottle of DUR-928 powder to suspend the drug substance, and the entire bottle content is orally dosed, followed by two rinses with water. Study staff will administer all doses.