A Study to Evaluate the Pharmacokinetics, Safety and Tole... | NCT06698549

NCT06698549

Status Module

Sponsor/Collaborators Module

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with Severe Renal Impairment	Experimental	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	Drug: ALG-097558
Subjects with Normal Renal Function	Experimental	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	Drug: ALG-097558
Subjects with Mild Renal Impairment (Optional)	Experimental	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	Drug: ALG-097558
Subjects with Moderate Renal Impairment (Optional)	Experimental	Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	Drug: ALG-097558

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALG-097558	Drug	Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)	Subjects with Mild Renal Impairment (Optional) Subjects with Moderate Renal Impairment (Optional)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration Time Curve [AUC]	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
Maximum Plasma Concentration [Cmax]	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
Minimum Plasma Concentration [Cmin]	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
C0 [Predose]	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
Half-life [t1/2]	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
Time to Maximum Plasma Concentration [Tmax]	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
Apparent Clearance (CL/F)	Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma	Pre-dose (-0.75 hours) up to Day 8
Apparent Volume of Distribution (V/F)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 (July 2017)	Up to 20 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria for All Subjects:

Male and Female between 18 and 75 years old
Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)
Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy

Inclusion Criteria for Subjects with Normal Renal Function:

Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and 12-lead electrocardiogram (ECG) assessment
Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
Normal renal function (estimated Glomerular Filtration Rate [eGFR] ≥90 mL/min) with no known or suspected renal impairment

Inclusion Criteria for Subjects with Impaired Renal Function:

Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration
Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening
Subjects must have a 12-lead ECG and vital signs assessment that meet 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 and 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 (subjects with normal renal function) or unstable (subjects with renal impairment) cardiac disease etc.
Subjects with a history of clinically significant drug allergy
Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
Unwilling to abstain from alcohol use for 48 hours 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 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >2x upper limit of normal (ULN)
Subjects with bilirubin (total, direct) >1.5x ULN (unless Gilbert's is suspected)
Positive pregnancy test; females must not be pregnant at enrollment

Exclusion Criteria for Subjects with Normal Renal Function:

1. Hemoglobin <10 g/dL

Exclusion Criteria for Subjects with Impaired Renal Function:

Participants requiring hemodialysis and/or peritoneal dialysis
Hemoglobin <9 g/dL

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States
Orlando Clinical Research Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
FG001	Subjects With Normal Renal Function

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 6, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Subjects with Normal Renal Function

Subjects with Severe Renal Impairment

The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.

Arm/Group Information

ID	Title	Description
BG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
BG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
BG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
BG003	Subjects With Moderate Renal Impairment (Optional)	Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0016 BG0020 BG0030 BG00412

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053.3± 14.01 BG00147.3± 6.38 BG00450.3± 10.84

Sex: Female, Male

Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG001

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG001

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG001

Region of Enrollment

Number

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0006 BG0016 BG004

Height

Mean

Standard Deviation

centimetres

Title

Denominators

Categories

Title	Measurements
	BG000171.18± 9.839 BG001175.62± 7.612 BG004

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00080.47± 23.584 BG00177.08± 7.184 BG004

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.20± 6.073 BG00124.95± 0.517 BG004

Baseline eGFR

Mean

Standard Deviation

(mL/min)/1.73 m^2

Title

Denominators

Categories

Title	Measurements
	BG00016.83± 9.174 BG001114.50± 10.784 BG004

eGFR BSA adjusted

Mean

Standard Deviation

mL/min

Title

Denominators

Categories

Title	Measurements
	BG00016.75± 7.998 BG001124.00± 14.782 BG004

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Concentration Time Curve [AUC]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng.h/mL

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)	Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.

Units	Counts
Participants	OG0006 OG0016 OG0020 OG003

Title	Denominators	Categories
Total ALG-097558 - AUC0-12 Day 1	ParticipantsOG0006 ParticipantsOG0016 ParticipantsOG0020 ParticipantsOG003

Primary

Maximum Plasma Concentration [Cmax]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003

Primary

Minimum Plasma Concentration [Cmin]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003

Primary

C0 [Predose]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)

Primary

Half-life [t1/2]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)

Primary

Time to Maximum Plasma Concentration [Tmax]

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Median

Full Range

hours

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)

Primary

Apparent Clearance (CL/F)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)

Primary

Apparent Volume of Distribution (V/F)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

Posted

Geometric Mean

Geometric Coefficient of Variation

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003

Primary

Total Amount of Drug Excreted in Urine (Ae)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

Posted

Mean

Standard Deviation

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)

Primary

Renal Clearance (CLr)

Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

Posted

Mean

Standard Deviation

L/h

Pre-dose (-0.75 hours) up to Day 8

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG003	Subjects With Moderate Renal Impairment (Optional)

Secondary

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 (July 2017)

Posted

Number

Number of participants

Up to 20 Days

ID	Title	Description
OG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.
OG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subjects With Severe Renal Impairment	Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	6	6	1	6
EG001	Subjects With Normal Renal Function	Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	6	6	1	6
EG002	Subjects With Mild Renal Impairment (Optional)	Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	0	0	0	0
EG003	Subjects With Moderate Renal Impairment (Optional)	Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours [Q12H]) for 6 days for 11 total doses.	0	0	0	0

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment		EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 affected0 at risk EG0030 affected0 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment		EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 affected0 at risk EG003

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Title	Measurements
	OG0001300± 97.3 OG0011450± 21.6