COVID-19 Clinical Trial
Official title:
A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558
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
Status | Recruiting |
Enrollment | 144 |
Est. completion date | July 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hammersmith Medicines Research | London |
Lead Sponsor | Collaborator |
---|---|
Aligos Therapeutics |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 11 days for Part 1 | |
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 20 days for Part 2 | |
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 20 days for Part 3 | |
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 23 days for Part 4 | |
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 28 days for Part 5 | |
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 17 days for Part 6 | |
Primary | Area under the concentration time curve [AUC] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days | |
Primary | Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days | |
Primary | Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days | |
Primary | Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days | |
Primary | C0 [predose] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days | |
Primary | Half-life [t1/2] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days | |
Primary | Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days | |
Primary | Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days | |
Primary | Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days | |
Primary | Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days | |
Primary | C0 [predose] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days | |
Primary | Half-life [t1/2] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days | |
Primary | Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days | |
Primary | Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days | |
Primary | Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days | |
Primary | Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days | |
Primary | C0 [predose] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days | |
Primary | Half-life [t1/2] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days | |
Secondary | Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days | |
Secondary | Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days | |
Secondary | Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days | |
Secondary | Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days | |
Secondary | Half-life [t1/2] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days | |
Secondary | C0 [predose] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days | |
Secondary | Dose Proportionality | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
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