Study of Midazolam in Healthy Adults

NCT04679623 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: RLM-559-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.

Conditions

Status Epilepticus

Outcome Measures

Primary Outcomes (8)

• number of participants with local injection site changes

  28 days

• number of participants with systemic changes in physical exam

  28 days

• number of participants with vital signs changes resulting in a serious adverse event

  28 days

• number of participants with ECG changes resulting in a serious adverse event

  28 days

• number of participants with laboratory changes resulting in a serious adverse event

  28 days

• time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection

  28 days

• The elimination rate constant (ke) will be estimated

  28 days

• The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-∞)

  28 days

Secondary Outcomes (3)

• Relative bioavailability will be obtained by analysis of Cmax

  28 days

• Relative bioavailability will be obtained by analysis of AUC0-last

  28 days

• Relative bioavailability will be obtained by analysis of AUC0-∞

  28 days

Study Arms (2)

Midazolam Injection

EXPERIMENTAL

Midazolam injection, 10 mg

Combination Product: Midazolam

Seizalam™

ACTIVE COMPARATOR

Seizalam, 10 mg

Drug: Seizalam

Interventions

Midazolam COMBINATION_PRODUCT

Midazolam Injection, 10mg

Midazolam Injection

Seizalam DRUG

Seizalam, 10 mg

Seizalam™

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rafa Laboratories: lead
• Alachua Government Services, Inc.: collaborator
• Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical: collaborator

Study Sites (1)

Wake Research

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Status Epilepticus

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 22, 2020
• Study Start: June 9, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

US (1)