Phase
Condition
Covid-19
Treatment
Midazolam
ALG-097558 in solution formulation
ALG-097558
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for All Subjects:
Male and Female between 18 and 55 years old
BMI 18.0 to 32.0 kg/m^2
Female subjects must have a negative serum pregnancy test at screening
Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
Exclusion Criteria for All Subjects:
Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Excessive use of alcohol defined as regular consumption of ≥14 units/week
Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
Study Design
Connect with a study center
Hammersmith Medicines Research
London,
United KingdomSite Not Available
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