A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.

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

Details

• Lead Sponsor: Biota Scientific Management Pty Ltd
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening;

• Capable of giving written informed consent;

• Subject is able to understand and comply with the protocol requirements, instructions and restrictions;

• Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;

• Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam/gel/film/cream/suppository); and

• Female subjects must not be breastfeeding or pregnant.

Exclusion Criteria:

• Positive results for Hepatitis B, Hepatitis C, or HIV;

• Frequent use (defined as > 5 times/day) of tobacco products, including cigarettes, cigars, chewing tobacco;

• A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;

• Current or recent respiratory infection (defined as within 14 days of first study visit participation)

• Presence or history of significant allergy;

• Clinically significant abnormalities noted on ECG;

• Screening vital signs representing sustained elevated systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure <55 mmHg or >90 mmHg.

• Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;

• Safety laboratory abnormalities noted at screening which are clinically significant

• Current or defined history of abuse of alcohol or illicit drugs;

• A positive pregnancy test at screening;

• Poor vein access or fear of venipuncture or sight of blood; and

• Regular consumption of alcohol defined as either > 2 units (glass or shot) of alcoholic beverages per day or > 14 units per week.