Status:
COMPLETED
Study of Midazolam in Healthy Adults
Lead Sponsor:
Rafa Laboratories
Collaborating Sponsors:
Alachua Government Services, Inc.
Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical
Conditions:
Status Epilepticus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared w...
Eligibility Criteria
Inclusion
- Can understand and provide signed informed consent
- Is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ECG are within normal range
- Has a willingness to comply and be available for all protocol procedures
- Is between age 18 and 55 years, inclusive on the day of injection
- If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to injection Note: A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful Essure placement with documented confirmation test at least 3 months after the procedure
- If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception up to 1 month after the end of study visit Note: Acceptable contraception methods are restricted to effective devices (approved oral contraceptives, Intrauterine Contraceptive Devices, NuvaRing®)
- If the subject is male, he agrees to practice abstinence from sexual intercourse with women or use acceptable contraception up to 1 month after the end of study visit
- Has a body mass index (BMI) ≥18.0 and ≤26.0 kg/m2 at screening
- Has a negative urine drug screen
- Has a negative breathalyzer test
- Subject is not taking any medications or St. John's wort and agrees to avoid grapefruit juice and alcohol until study completion on Day 28
- Subject agrees to not take any vitamins or supplements 48 hours prior to dosing
- Is available for follow-up for the duration of the study
Exclusion
- Received treatment with another investigational drug within 28 days of initial dosing
- Has a current or history of drug and /or alcohol abuse
- Is pregnant or breastfeeding woman
- Has hypersensitivity or allergy to midazolam
- Has hypersensitivity or allergy to benzodiazepines
- Has a history of cardiovascular, pulmonary, neurological, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or psychiatric disease or any other reason, in the opinion of the investigator, that the patient should not participate
- Tests positive for HIV-1, HIV-2, HbsAg, hepatitis C antibody, or syphilis
- Has had a blood donation in the 8 weeks prior to the study period start date
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04679623
Start Date
June 9 2021
End Date
September 17 2021
Last Update
March 17 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Research
Raleigh, North Carolina, United States, 27612