Phase 1
N=51
Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT06945276 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: 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 — 12800; 41900; 541; 662 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ALG-097558 (Drug); Dabigatran (Drug); Itraconazole (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
12800; 41900; 541; 662; 24800; 25200 | — |
| PRIMARY 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 |
11900; 41700; 495; 638; 24700; 25000 | — |
| PRIMARY Elimination Half-life (t1/2):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B |
3.19; 5.72; 9.15; 9.31; 3.47; 6.96 | — |
| PRIMARY Maximum Observed Concentration (Cmax):ALG-097558 in Plasma in Part A and Part C, Dabigatran (Total) in Plasma in Part B |
2730; 4850; 58.6; 80.6; 4720; 3470 | — |
| PRIMARY Time of Observed Maximum Concentration (Tmax):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf) for ALG-097730 Plasma in Part A and Part C |
3140; 7000; 6530; 6000; 6360 | — |
| PRIMARY 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 |
3100; 6930; 6600; 5940; 6200 | — |
| PRIMARY Elimination Half-life (t1/2) for ALG-097730 in Plasma in Part A and Part C |
4.95; 6.72; 5.43; 7.07; 6.54 | — |
| PRIMARY Maximum Observed Concentration (Cmax) for ALG-097730 in Plasma in Part A and Part C |
533; 577; 1010; 758; 983 | — |
| PRIMARY Time of Observed Maximum Concentration (Tmax) for ALG-097730 in Part A and Part C |
NA; NA; NA; NA; NA | — |
| SECONDARY Maximum Observed Concentration (Cmax) of ALG-097558 in Plasma After Co-administration With a Single Dose of Dabigatran in Part B |
4060 | — |
| SECONDARY Time of Observed Maximum Concentration (Tmax):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B |
NA | — |
| SECONDARY 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 |
20800 | — |
| SECONDARY Elimination Half-life (t1/2) of ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B |
2.11 | — |
| SECONDARY Time of Last Measurable Concentration (Tlast):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B |
NA | — |
| SECONDARY Maximum Observed Concentration (Cmax) of ALG-097730 in Plasma After Co-administration of ALG-097558 With a Single Dose of Dabigatran in Part B |
897 | — |
| SECONDARY Time of Observed Maximum Concentration (Tmax):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B |
NA | — |
| SECONDARY 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 |
5640 | — |
| SECONDARY 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 |
2.42 | — |
| SECONDARY Time of Last Measurable Concentration (Tlast):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B |
NA | — |
| SECONDARY 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 |
0.263 | — |
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). In addition, this study will evaluate the relative bioavailability and food effect of a new tablet formulation for ALG-097558.
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.
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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) /=110 to /=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 /=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
Data sourced from ClinicalTrials.gov (NCT06945276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.