COVID-19Phase 1NCT06945276

Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers

A Phase 1 study testing ALG-097558, Dabigatran and Itraconazole in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: ALG-097558, Dabigatran and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 13 May 2025to 1 Aug 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant is able to read the written informed consent, states willingness to comply with all study procedures, and is anticipated to be available for all study visits.
Male or female adults between 18 and 65 years of age, inclusive.
Female participants must either be postmenopausal*, permanently sterile, or of childbearing potential with acceptable birth control methods*.
Postmenopausal: a postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation, confirmed by a high follicle-stimulating hormone (FSH) level in the postmenopausal range at screening. NOTE: If there is a question about menopausal status in women on hormone replacement therapy (HRT), the woman will be required to use one of the protocol-defined non-estrogen-containing hormonal highly effective contraceptive methods if she wishes to continue HRT during the study.
Permanently sterile: methods include hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or bilateral tubal occlusion.
Women of childbearing potential (WOCBP): are only eligible if they and any non-sterile, male sexual partners agree to use protocol-defined highly effective (dependent or independent) contraceptive therapy, from the start of dosing until at least 90 days after the last dose. Acceptable method of contraception, hormonal contraceptives (e.g., oral, injectable, implantable, insertable, and transdermal patch), intrauterine device (with or without hormones), or double-barrier method (e.g., condom and spermicide) for 30 days prior to Screening, during the study, and for 90 days following the last administration of investigational product (IP). WOCBP must also agree to refrain from egg donations during the study and for at least 90 days following the last administration of IP.

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Male participants who must agree to wear a condom with spermicide during sexual intercourse.*
These contraceptive measures must be implemented, at a minimum, from the start of dosing until at least 90 days after the last dose. Male volunteers must agree not to donate sperm during the study and for 90 days following the last administration of IP.
Participants must have a body mass index (BMI) of 18.0 to 32.0 kg/m^2, extremes included.
Participants must be nonsmokers for at least 3 months prior to randomization/enrollment.
Participants must have a 12-lead electrocardiogram (ECG) that considered in an acceptable range for inclusion.*
Criteria includes: heart rate between 40 and 100 beats per minute [bpm], extremes included; QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) </= 450 ms (males) or </= 470 ms (females); QRS interval </=120 ms; PR interval >/=110 to </=220 ms; and in addition to fulfilling the above ECG criteria, ECG morphology must have no clinically significant abnormalities observed.
NOTE: Retesting of an apparently exclusionary ECG will be allowed once without prior approval from the Sponsor (following ECG collections described in Section 8.3.4). Participants with a retest ECG without clinically significant abnormalities as per this inclusion criterion may be included.
Participants must be deemed to be in good overall health by the Investigator on the basis of a medical evaluation* performed at Screening.
Medical evaluation that includes the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs, and the results of blood chemistry, blood coagulation and hematology tests, and urinalysis.
Subject must be willing and able to adhere to the Prohibited Medication requirements and Special Precautions as specified in the protocol.

Who cannot join

Participants with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose risk in administering study drug to the subject.* *Additionally illnesses that could prevent, limit, or confound the protocol specified assessments or study results' interpretation. This may include, but is not limited to, renal, cardiac, vascular, pulmonary, gastrointestinal, hepatologic, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
Participants with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome or clinical evidence at screening of significant or unstable cardiac disease.*
Risk factors for Torsade de Pointes syndrome include hypokalemia and family history of long QT syndrome. Clinical evidence of cardiac disease include angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, clinically significant ECG abnormalities, moderate to severe valvular disease or uncontrolled hypertension. Evidence of heart block or bundle branch block, inclusive of first-degree AV block and incomplete bundle branch block, on ECG is also exclusionary.
Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides or drug allergy witnessed in previous studies with experimental drugs.
Participants with a recent (within 1 year of randomization/enrollment) history of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use.*
Use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary. Cannabis use is also not exclusionary unless detected at screening or Day -1 (Exclusion Criteria 7).

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Excessive use of alcohol defined as regular consumption of >/=14 standard drinks/week .*
For current definition of a standard drink, refer to the National Institute on Alcohol Abuse and Alcoholism website.
Unwilling to abstain from alcohol use for 1 week prior to start of study through end of study follow up.
Positive results for urine drug screen for barbiturates, opiates, amphetamines, methadone, cocaine, benzodiazepines, or cannabinoids, alcohol or cotinine test at screening and Day - 1.
Participants with current viral infections.*
Viral infections include the following:
Hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]).
Hepatitis B infection defined as presence of HBsAg or HBV core antibody.
Hepatitis C virus (HCV) infection (confirmed by HCV antibody and/or HCV RNA). Participants who have been treated and achieved sustained virologic response >/=6 months prior to screening with HCV RNA < Lower limit of quantitation (LLOQ), target not detected, remain eligible.
Hepatitis E virus: Anti-HEV IgM-positive and/or detectable HEV RNA level (only applies to participants with history of living or traveling to an HEV epidemic area within 90 days of screening).
Human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening.
Acute infection at the time of randomization/enrollment. If an acute infection is considered resolved prior to randomization/enrollment, the subject remains eligible.
Male participants who plan to father a child while enrolled in this study or within 90 days after the last dose of study drug.
Women who are breastfeeding or planning to breastfeed throughout the duration of the study.
Use of any medications (prescription and Over-the-counter (OTC)), vitamins, and/or herbal supplements* within 1 week (or 5 half-lives, whichever is longer) prior to the first dose of study drug.
Exception of contraceptives and OTC doses of ibuprofen or acetaminophen of up to 3 doses per week
Use of prohibited medications (as described in Section 6.8.1) within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of study drug.
Consumption of grapefruit, grapefruit juice, and Seville oranges within 7 days prior to first study drug administration.
Consumption of apple or orange juice, citrus fruits, vegetables from the mustard green family*, and charbroiled meats within 7 days prior to first study drug administration.
Examples are kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard.
Consumption of any food or drink/beverage containing quinine (e.g., tonic, bitter lemon, bitter alcoholic beverages containing quinine) within 24 hours prior to study drug administration.
Participants having received an investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to screening.
Participants currently participating in another clinical or medical interventional research study.
Participants with any >/=Grade 1 laboratory result that is considered clinically significant by the Investigator at screening. (Grade 1 laboratory result that is not clinically significant is allowed.)
Clinically significant abnormal vital signs* (evaluated in the supine position after at least 5 minutes of rest), confirmed with retesting after at least 5 minutes of additional rest.
Abnormal vital signs are based on the following criteria:
Systolic blood pressure: <90 or >145 mmHg
Diastolic blood pressure: <50 or >95 mmHg
Pulse rate: <45 or >100 beats per minute
Temperature: <36.1 degrees Celsius or >38.0 degrees Celsius
Physical examination findings that are considered clinically significant per study principal investigator and/or study physician and likely to adversely impact study conduct and/or interpretation are exclusionary.
Participants who had major surgery (e.g., requiring general anesthesia) within 12 weeks before screening, planned during the study, or within 4 weeks after the last dose of study drug.*
This includes participants who will not have fully recovered from surgery by the time the participant is expected to participate in the study. NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
Participants with renal dysfunction*
Includes estimated creatinine clearance <80 mL/min/1.73 m^2 at screening or Day -1, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. CKD-EPI should not be corrected for participants of African ancestry.
Participants with alanine aminotransferase (ALT) values >1.2× upper limit of normal (ULN) at screening or Day -1.
Participants who donated blood or plasma recently*
Recently defined as within 56 days prior to screening, or loss of whole blood of more than 500 mL within 30 days prior to Day-1, or receipt of a blood transfusion within 1 year of study enrollment; receipt of Plasma 7 days prior to screening.
Participant is an employee of the Sponsor, the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.* *This extends to family members of the employees or the Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dr. Vince Clinical Research
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate Relative Bioavailability and Food Effect of an ALG-097558 Tablet Formulation and the Drug-Drug Interaction Potential of ALG-097558 and Its Metabolite ALG-097730 in Healthy Volunteers

This study consists of 3 parts, all conducted in healthy volunteers (HV). Study Parts A and B are designed to assess the perpetrator or victim DDI risk of ALG-097558 mediated by CYP/P-gp interactions in healthy adult subjects. Part A will evaluate the potential impact of itraconazole, a CYP3A potent inhibitor, while Part B will investigate the potential impact of ALG-097558 (perpetrator) on dabigatran etexilate, a P-gp transporter substrate. Study Part C is designed to study the bioavailability of a new formulation of the ALG-097558 tablet and the food effect on this tablet.

Read the detailed description

This study consists of 3 parts, all conducted in healthy volunteers (HV). As ALG-097558 is a substrate of CYP3A4 and P-gp transporters, any concomitant administration of an inhibitor or inducer drug may alter its exposures. Part A will evaluate the potential impact of itraconazole, a CYP3A potent inhibitor, on the ALG-097558 (victim) systemic exposure in a single group, partially-blinded study. Part B will investigate the potential impact of ALG-097558 (perpetrator) on dabigatran etexilate, a P-gp transporter substrate in a single group, open-label study. Study Part C is designed to study the bioavailability of a new formulation of the ALG-097558 tablet and the food effect on this tablet in an open-label, randomized, crossover study.

This study has one primary objective for each part of the study. For Part A: to evaluate the effect of a CYP3A4 inhibitor/Pg-p inhibitor, itraconazole, on the pharmacokinetics (PK) of ALG-097558 and the metabolite, ALG-097730. For Part B: to evaluate the effect of multiple doses of ALG-097558 on the pharmacokinetics of a P-gp substrate, dabigatran. For Part C: to evaluate the relative bioavailability of 2 different tablet formulations of ALG-097558 and effect of food on the pharmacokinetics of ALG-097558 and the metabolite, ALG-097730.The study has secondary objectives for each part of the study as well. For Part A: to evaluate the safety and tolerability of single doses of ALG-097558 in HV participants when administered as monotherapy or in combination with itraconazole. For part B: to evaluate the safety and tolerability and PK of multiple doses of ALG-097558 in HV participants when administered alone or in combination with dabigatran. For part C: to evaluate the safety and tolerability of single doses of ALG-097558 in HV participants.

Conditions: COVID-19
Being tested: ALG-097558, Dabigatran, Itraconazole, Placebo
Keywords: ALG-097558, Dabigatran, Drug-Drug Interaction, Healthy Subjects, Interventional, Itraconazole, SARS-CoV-2, Tablet Formulation
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALG-097558Drug
A selective, reversible, and potent inhibitor of the SARS-CoV-2 3CLpro with pan-coronavirus activity
DabigatranDrug
A direct thrombin inhibitor approved for the treatment and prevention of blood clots to reduce the risk of stroke
ItraconazoleDrug
A substrate and strong dual inhibitor of CYP3A4/P-glycoprotein (P-gp)
PlaceboOther
Placebo

Study groups in NCT06945276
Study group	Role	What they receive
Part A Arm	Experimental	A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12) Receives: Drug: ALG-097558; Drug: Itraconazole; Other: Placebo
Part B Arm	Experimental	A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24) Receives: Drug: ALG-097558; Drug: Dabigatran
Part C Sequence 1 Arm	Experimental	A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Receives: Drug: ALG-097558
Part C Sequence 2 Arm	Experimental	A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Receives: Drug: ALG-097558
Part C Sequence 3 Arm	Experimental	A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5) Receives: Drug: ALG-097558

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf): ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for AUC0-inf.
The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for AUClast.
The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Elimination Half-life (t1/2):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Drug-drug interactions for t1/2 were evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A and Part C) and dabigatran (Part B)
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Maximum Observed Concentration (Cmax):ALG-097558 in Plasma in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for Cmax.
The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A and Part C) and dabigatran (Part B)
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf) for ALG-097730 Plasma in Part A and Part C
Drug-drug interactions for AUC0-inf were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097730 in Plasma in Part A and Part C
Drug-drug interactions for AUClast were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Elimination Half-life (t1/2) for ALG-097730 in Plasma in Part A and Part C
Drug-drug interactions for t1/2 were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Maximum Observed Concentration (Cmax) for ALG-097730 in Plasma in Part A and Part C
Drug-drug interactions for Cmax were evaluated using the geometric mean ratio (log-transformed)in Part A and Part C
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Time of Observed Maximum Concentration (Tmax) for ALG-097730 in Part A and Part C
Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Measured: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Secondary outcomes (11)

Maximum Observed Concentration (Cmax) of ALG-097558 in Plasma After Co-administration With a Single Dose of Dabigatran in Part B
PK parameter of Cmax was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: 0 to 72 hours post dose on Days 1 to 8
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
PK parameter of Tmax was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
PK parameter of AUClast was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Elimination Half-life (t1/2) of ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
PK parameter of t1/2 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Time of Last Measurable Concentration (Tlast):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
PK parameter of Tlast was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Maximum Observed Concentration (Cmax) of ALG-097730 in Plasma After Co-administration of ALG-097558 With a Single Dose of Dabigatran in Part B
PK parameter of Cmax for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: 0 to 72 hours post dose on Days 1 to 8
Time of Observed Maximum Concentration (Tmax):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
PK parameter of Tmax for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for Metabolite ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
PK parameter of AUClast for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Elimination Half-life (t1/2) for Metabolite ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
PK parameter of t1/2 for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Time of Last Measurable Concentration (Tlast):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
PK parameter of Tlast for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8
Metabolite to Parent Area Under the Concentration-time Curve Ratio From Time Zero to the Last Measurable Concentration (MPAUClast) for ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
PK parameter of MPAUClast for metabolite ALG-097730 was assessed following 600 mg ALG-097558 Q12H co-administered with a single 75 mg dabigatran dose
Measured: Part B-0 to 72 hours post dose on Days 1 to 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 20251 Aug 2025

First posted25 Apr 2025
Study start13 May 2025
Primary completion1 Aug 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06945276
Sponsor's protocol ID: 24-0026
Status last verified: 18 Apr 2025
First submitted: 18 Apr 2025
Last updated: 18 May 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate Relative Bioavailability and Food Effect of an ALG-097558 Tablet Formulation and the Drug-Drug Interaction Potential of ALG-097558 and Its Metabolite ALG-097730 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06945276
Acronym / sponsor ID: 24-0026
Conditions: COVID-19
Keywords: ALG-097558, Dabigatran, Drug-Drug Interaction, Healthy Subjects, Interventional, Itraconazole, SARS-CoV-2, Tablet Formulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 13 May 2025 (actual)
Primary completion: 1 Aug 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 25 Apr 2025 (actual)
Results: Posted 18 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Part A Arm	Experimental	Drug: ALG-097558, Drug: Itraconazole, Other: PlaceboA single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)
Part B Arm	Experimental	Drug: ALG-097558, Drug: DabigatranA single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24)
Part C Sequence 1 Arm	Experimental	Drug: ALG-097558A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5)
Part C Sequence 2 Arm	Experimental	Drug: ALG-097558A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5)
Part C Sequence 3 Arm	Experimental	Drug: ALG-097558A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Participant is able to read the written informed consent, states willingness to comply with all study procedures, and is anticipated to be available for all study visits.
Male or female adults between 18 and 65 years of age, inclusive.
Female participants must either be postmenopausal*, permanently sterile, or of childbearing potential with acceptable birth control methods*.
Postmenopausal: a postmenopausal state is defined as no menses for at least 12 months without an alternative medical explanation, confirmed by a high follicle-stimulating hormone (FSH) level in the postmenopausal range at screening. NOTE: If there is a question about menopausal status in women on hormone replacement therapy (HRT), the woman will be required to use one of the protocol-defined non-estrogen-containing hormonal highly effective contraceptive methods if she wishes to continue HRT during the study.
Permanently sterile: methods include hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or bilateral tubal occlusion.

Key exclusion criteria (45 listed)

Participants with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose risk in administering study drug to the subject.* *Additionally illnesses that could prevent, limit, or confound the protocol specified assessments or study results' interpretation. This may include, but is not limited to, renal, cardiac, vascular, pulmonary, gastrointestinal, hepatologic, endocrine, neurologic, dermatologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
Participants with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome or clinical evidence at screening of significant or unstable cardiac disease.*
Risk factors for Torsade de Pointes syndrome include hypokalemia and family history of long QT syndrome. Clinical evidence of cardiac disease include angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, clinically significant ECG abnormalities, moderate to severe valvular disease or uncontrolled hypertension. Evidence of heart block or bundle branch block, inclusive of first-degree AV block and incomplete bundle branch block, on ECG is also exclusionary.
Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides or drug allergy witnessed in previous studies with experimental drugs.
Participants with a recent (within 1 year of randomization/enrollment) history of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use.*

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALG-097558A selective, reversible, and potent inhibitor of the SARS-CoV-2 3CLpro with pan-coronavirus activity	Drug	Part A Arm, Part B Arm, Part C Sequence 1 Arm, Part C Sequence 2 Arm, Part C Sequence 3 Arm
DabigatranA direct thrombin inhibitor approved for the treatment and prevention of blood clots to reduce the risk of stroke	Drug	Part B Arm
ItraconazoleA substrate and strong dual inhibitor of CYP3A4/P-glycoprotein (P-gp)	Drug	Part A Arm
PlaceboPlacebo	Other	Part A Arm

Primary outcome

Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf): ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for AUC0-inf. The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for AUClast. The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.
Elimination Half-life (t1/2):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for t1/2 were evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A and Part C) and dabigatran (Part B)
Maximum Observed Concentration (Cmax):ALG-097558 in Plasma in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for Cmax. The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A and Part C) and dabigatran (Part B)
Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf) for ALG-097730 Plasma in Part A and Part C
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for AUC0-inf were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097730 in Plasma in Part A and Part C
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for AUClast were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Elimination Half-life (t1/2) for ALG-097730 in Plasma in Part A and Part C
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for t1/2 were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C
Maximum Observed Concentration (Cmax) for ALG-097730 in Plasma in Part A and Part C
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for Cmax were evaluated using the geometric mean ratio (log-transformed)in Part A and Part C
Time of Observed Maximum Concentration (Tmax) for ALG-097730 in Part A and Part C
Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C

11 secondary outcomes

Maximum Observed Concentration (Cmax) of ALG-097558 in Plasma After Co-administration With a Single Dose of Dabigatran in Part B
Time frame: 0 to 72 hours post dose on Days 1 to 8
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Elimination Half-life (t1/2) of ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Time of Last Measurable Concentration (Tlast):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Maximum Observed Concentration (Cmax) of ALG-097730 in Plasma After Co-administration of ALG-097558 With a Single Dose of Dabigatran in Part B
Time frame: 0 to 72 hours post dose on Days 1 to 8
Time of Observed Maximum Concentration (Tmax):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for Metabolite ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Elimination Half-life (t1/2) for Metabolite ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Time of Last Measurable Concentration (Tlast):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8
Metabolite to Parent Area Under the Concentration-time Curve Ratio From Time Zero to the Last Measurable Concentration (MPAUClast) for ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B
Time frame: Part B-0 to 72 hours post dose on Days 1 to 8

Results and safety

Results posted to the registry on 18 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Arm	12	12
Part B Arm	24	23
Part C Sequence 1 Arm	5	5
Part C Sequence 2 Arm	5	5
Part C Sequence 3 Arm	5	5

Primary outcome: Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf): ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B

Time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Part A: ALG-097558 Dosed Alone n = 11	Part A: ALG-097558 With Itraconazole n = 12	Part B: Dabigatran Dosed Alone n = 22	Part B: Dabigatran With ALG-097558 n = 23	Part C: Formulation 1 Fasted n = 15	Part C: Formulation 2 Fasted n = 15	Part C: Formulation 2 Fed n = 14
Value	12800 (40.3)	41900 (47.7)	541 (56.8)	662 (64.5)	24800 (25.8)	25200 (25.5)	22100 (22.4)

Part A: ALG-097558 Dosed Alone vs Part A: ALG-097558 With Itraconazole: Geometric Mean Ratio: 347.917 (90% CI 331.23 to 365.45)
Part B: Dabigatran Dosed Alone vs Part B: Dabigatran With ALG-097558: Geometric Mean Ratio: 120.898 (90% CI 97.39 to 150.09)
Part C: Formulation 1 Fasted vs Part C: Formulation 2 Fasted: Geometric Mean Ratio: 101.489 (90% CI 96.55 to 106.68)

Primary outcome: Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B

Measure	Part A: ALG-097558 Dosed Alone n = 12	Part A: ALG-097558 With Itraconazole n = 12	Part B: Dabigatran Dosed Alone n = 24	Part B: Dabigatran With ALG-097558 n = 23	Part C: Formulation 1 Fasted n = 15	Part C: Formulation 2 Fasted n = 15	Part C: Formulation 2 Fed n = 15
Value	11900 (44.5)	41700 (47.8)	495 (71.5)	638 (66.3)	24700 (25.8)	25000 (25.5)	21900 (21.6)

Part A: ALG-097558 Dosed Alone vs Part A: ALG-097558 With Itraconazole: Geometric Mean Ratio: 346.147 (90% CI 330.24 to 362.82)
Part B: Dabigatran Dosed Alone vs Part B: Dabigatran With ALG-097558: Geometric Mean Ratio: 119.229 (90% CI 96.96 to 146.62)
Part C: Formulation 1 Fasted vs Part C: Formulation 2 Fasted: Geometric Mean Ratio: 100.908 (90% CI 95.96 to 106.12)

Primary outcome: Elimination Half-life (t1/2):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B

Measure	Part A: ALG-097558 Dosed Alone n = 11	Part A: ALG-097558 With Itraconazole n = 12	Part B: Dabigatran Dosed Alone n = 22	Part B: Dabigatran With ALG-097558 n = 23	Part C: Formulation 1 Fasted n = 15	Part C: Formulation 2 Fasted n = 15	Part C: Formulation 2 Fed n = 14
Value	3.19 (34.3)	5.72 (45.6)	9.15 (20.6)	9.31 (23.9)	3.47 (32.3)	6.96 (39.9)	3.10 (9.72)

Primary outcome: Maximum Observed Concentration (Cmax):ALG-097558 in Plasma in Part A and Part C, Dabigatran (Total) in Plasma in Part B

Measure	Part A: ALG-097558 Dosed Alone n = 12	Part A: ALG-097558 With Itraconazole n = 12	Part B: Dabigatran Dosed Alone n = 24	Part B: Dabigatran With ALG-097558 n = 23	Part C: Formulation 1 Fasted n = 15	Part C: Formulation 2 Fasted n = 15	Part C: Formulation 2 Fed n = 15
Value	2730 (38.9)	4850 (35.8)	58.6 (72.2)	80.6 (67.1)	4720 (24.7)	3470 (21.6)	4320 (27.0)

Part A: ALG-097558 Dosed Alone vs Part A: ALG-097558 With Itraconazole: Geometric Mean Ratio: 177.485 (90% CI 160.93 to 195.74)
Part B: Dabigatran Dosed Alone vs Part B: Dabigatran With ALG-097558: Geometric Mean Ratio: 133.416 (90% CI 105.18 to 169.23)
Part C: Formulation 1 Fasted vs Part C: Formulation 2 Fasted: Geometric Mean Ratio: 73.621 (90% CI 67.27 to 80.58)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Arm-Placebo	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Part A Arm-ALG-097558 (Alone)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part A Arm-Itraconazole (Alone)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Part A Arm-Itraconazole + Placebo	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Part A Arm-Itraconazole + ALG-097558	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part B Arm-Dabigatran (Alone)	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Part B Arm-ALG-097558 (Alone)	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Part B Arm-ALG-097558 + Dabigatran	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Part C Arm-Sequence 1-Formulation 1 Fasted	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Part C Arm-Sequence 1-Formulation 2 Fasted	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Part C Arm-Sequence 1-Formulation 2 Fed	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Part C Arm-Sequence 2 (Formulation 2 Fasted)	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Part C Arm-Sequence 2 (Formulation 2 Fed)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Part C Arm-Sequence 2 (Formulation 1 Fasted)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Part C Arm-Sequence 3 (Formulation 2 Fed)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Part C Arm-Sequence 3 (Formulation 1 Fasted)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Part C Arm-Sequence 3 (Formulation 2 Fasted)	0 of 5 (0%)	2 of 5 (40%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALG-097558, Dabigatran and Itraconazole in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf): ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B (time frame: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06945276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.