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
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
July 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2024
CompletedApril 8, 2025
September 1, 2024
10 months
April 10, 2023
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (24)
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
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
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
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
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
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
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
C0 [predose]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
Half-life [t1/2]
Pharmacokinetic parameters of Midazolam and applicable metabolites
Predose (-2 hours) up to 11 days
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
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
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
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
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
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
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
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
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
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
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
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 Outcomes (7)
Maximum plasma concentration [Cmax]
Predose (-0.75 hours) up to 19 days
Area under the concentration time curve [AUC]
Predose (-0.75 hours) up to 19 days
Time to maximum plasma concentration [Tmax]
Predose (-0.75 hours) up to 19 days
Minimum plasma concentration [Cmin]
Predose (-0.75 hours) up to 19 days
Half-life [t1/2]
Predose (-0.75 hours) up to 19 days
- +2 more secondary outcomes
Study Arms (6)
ALG-097558
EXPERIMENTALOral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days
Placebo
PLACEBO COMPARATOROral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days
ALG-097558 and Midazolam
EXPERIMENTALOral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers
ALG-097558, Placebo, and, Itraconazole
EXPERIMENTALOral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.
ALG-097558 and Carbamazepine
EXPERIMENTALOral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers
ALG-097558 Bioavailability
EXPERIMENTALOral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers
Interventions
single or multiple doses of ALG-097558
ALG-097558 in solution administered in fasted state
ALG-097558 in tablet administered in fasted and fed state
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Medicines Research
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2023
First Posted
May 3, 2023
Study Start
July 4, 2023
Primary Completion
April 29, 2024
Study Completion
April 29, 2024
Last Updated
April 8, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share