A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840952
• Other study ID #: ALG-097558-701
• Status: Recruiting
• Phase: Phase 1
• Start date: July 4, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Aligos Therapeutics
• Contact: Stanley Wang
• Phone: +1 650 222 7159
• Email: swang[@]aligos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• ALG-097558
single or multiple doses of ALG-097558
• Placebo
single or multiple doses of placebo
• Midazolam
Multiple doses of Midazolam
• Itraconazole
Multiple doses of Itraconazole
• Carbamazepine
Multiple doses of Carbamazepine
• ALG-097558 in solution formulation
ALG-097558 in solution administered in fasted state
• ALG-097558 in tablet formulation
ALG-097558 in tablet administered in fasted and fed state

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Aligos Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

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