Status:
COMPLETED
A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
Lead Sponsor:
Biota Scientific Management Pty Ltd
Conditions:
Drug-Drug Interaction Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 cytochro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02204501
Start Date
May 1 2014
End Date
June 1 2014
Last Update
May 30 2018
Active Locations (1)
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1
Prism Clinical Research
Saint Paul, Minnesota, United States, 55114