COVID-19
Conditions
Keywords
Healthy Volunteer
Brief summary
A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers
Interventions
DRUGALG-097558
single or multiple doses of ALG-097558
DRUGPlacebo
single or multiple doses of placebo
DRUGMidazolam
Multiple doses of Midazolam
DRUGItraconazole
Multiple doses of Itraconazole
DRUGCarbamazepine
Multiple doses of Carbamazepine
DRUGALG-097558 in solution formulation
ALG-097558 in solution administered in fasted state
DRUGALG-097558 in tablet formulation
ALG-097558 in tablet administered in fasted and fed state
Sponsors
Aligos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Parts 1 and 2 are double blinded and randomized. Parts 3, 5, and 6 are open label and non-randomized. Part 4 is partially singled blinded non-randomized. Participants are blinded.
Intervention model description
Parts 1 and 2 of the study are parallel assignment, with 2 arms. Parts 3, 5, and 6 are fixed sequence, crossover studies. Part 4 is a partially placebo-controlled, fixed sequence, crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
for All Subjects: 1. Male and Female between 18 and 55 years old 2. BMI 18.0 to 32.0 kg/m\^2 3. Female subjects must have a negative serum pregnancy test at screening 4. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
Exclusion criteria
for All Subjects: 1. 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 2. 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. 3. Subjects with a history of clinically significant drug allergy 4. Excessive use of alcohol defined as regular consumption of ≥14 units/week 5. Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up 6. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection 7. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Half-life [t1/2] | Predose (-2 hours) up to 11 days | Pharmacokinetic parameters of Midazolam and applicable metabolites |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Up to 11 days for Part 1 | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 |
| Area under the concentration time curve [AUC] | Predose (-2 hours) up to 11 days | Pharmacokinetic parameters of Midazolam and applicable metabolites |
| Time to maximum plasma concentration [Tmax] | Predose (-2 hours) up to 11 days | Pharmacokinetic parameters of Midazolam and applicable metabolites |
| Maximum plasma concentration [Cmax] | Predose (-2 hours) up to 11 days | Pharmacokinetic parameters of Midazolam and applicable metabolites |
| Minimum plasma concentration [Cmin] | Predose (-2 hours) up to 11 days | Pharmacokinetic parameters of Midazolam and applicable metabolites |
| C0 [predose] | Predose (-2 hours) up to 11 days | Pharmacokinetic parameters of Midazolam and applicable metabolites |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration [Cmax] | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
| Area under the concentration time curve [AUC] | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
| Time to maximum plasma concentration [Tmax] | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
| Minimum plasma concentration [Cmin] | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
| Half-life [t1/2] | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
| C0 [predose] | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
| Dose Proportionality | Predose (-0.75 hours) up to 19 days | Pharmacokinetic parameters of ALG-097558 in plasma |
Countries
United Kingdom
Outcome results
None listed