COMPLETED

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

Conditions

COVID-19 ALG-097558 Dabigatran Drug-Drug Interaction Healthy Subjects Interventional Itraconazole SARS-CoV-2 Tablet Formulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05-13

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06945276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Male or female adults between 18 and 65 years of age, inclusive. 3. Female participants must either be postmenopausal\, permanently sterile\\, or of childbearing potential with acceptable birth control methods\\\. * 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. 4. Male participants who must agree to wear a condom with spermicide during sexual intercourse.\* 5. Participants must have a body mass index (BMI) of 18.0 to 32.0 kg/m\^2, extremes included. 6. Participants must be nonsmokers for at least 3 months prior to randomization/enrollment. 7. Participants must have a 12-lead electrocardiogram (ECG) that considered in an acceptable range for inclusion.\* 8. Participants must be deemed to be in good overall health by the Investigator on the basis of a medical evaluation\* performed at Screening. 9. Subject must be willing and able to adhere to the Prohibited Medication requirements and Special Precautions as specified in the protocol.	1. 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. 2. 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.\ 3. 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. 4. 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.\* 5. Excessive use of alcohol defined as regular consumption of \>/=14 standard drinks/week .\* 6. Unwilling to abstain from alcohol use for 1 week prior to start of study through end of study follow up. 7. Positive results for urine drug screen for barbiturates, opiates, amphetamines, methadone, cocaine, benzodiazepines, or cannabinoids, alcohol or cotinine test at screening and Day - 1. 8. Participants with current viral infections.\* * 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. 9. Male participants who plan to father a child while enrolled in this study or within 90 days after the last dose of study drug. 10. Women who are breastfeeding or planning to breastfeed throughout the duration of the study. 11. 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. 12. 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. 13. Consumption of grapefruit, grapefruit juice, and Seville oranges within 7 days prior to first study drug administration. 14. 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. 15. 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. 16. Participants having received an investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to screening. 17. Participants currently participating in another clinical or medical interventional research study. 18. 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.) 19. 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. * 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 20. 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. 21. 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.\* 22. Participants with renal dysfunction\* 23. Participants with alanine aminotransferase (ALT) values \>1.2× upper limit of normal (ULN) at screening or Day -1. 24. Participants who donated blood or plasma recently\* 25. 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.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Male or female adults between 18 and 65 years of age, inclusive.
3. Female participants must either be postmenopausal\*, permanently sterile\*\*, or of childbearing potential with acceptable birth control methods\*\*\*.
* 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.
4. Male participants who must agree to wear a condom with spermicide during sexual intercourse.\*
5. Participants must have a body mass index (BMI) of 18.0 to 32.0 kg/m\^2, extremes included.
6. Participants must be nonsmokers for at least 3 months prior to randomization/enrollment.
7. Participants must have a 12-lead electrocardiogram (ECG) that considered in an acceptable range for inclusion.\*
8. Participants must be deemed to be in good overall health by the Investigator on the basis of a medical evaluation\* performed at Screening.
9. Subject must be willing and able to adhere to the Prohibited Medication requirements and Special Precautions as specified in the protocol.

1. 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.
2. 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.\*
3. 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.
4. 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.\*
5. Excessive use of alcohol defined as regular consumption of \>/=14 standard drinks/week .\*
6. Unwilling to abstain from alcohol use for 1 week prior to start of study through end of study follow up.
7. Positive results for urine drug screen for barbiturates, opiates, amphetamines, methadone, cocaine, benzodiazepines, or cannabinoids, alcohol or cotinine test at screening and Day - 1.
8. Participants with current viral infections.\*
* 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.
9. Male participants who plan to father a child while enrolled in this study or within 90 days after the last dose of study drug.
10. Women who are breastfeeding or planning to breastfeed throughout the duration of the study.
11. 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.
12. 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.
13. Consumption of grapefruit, grapefruit juice, and Seville oranges within 7 days prior to first study drug administration.
14. 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.
15. 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.
16. Participants having received an investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to screening.
17. Participants currently participating in another clinical or medical interventional research study.
18. 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.)
19. 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.
* 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
20. 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.
21. 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.\*
22. Participants with renal dysfunction\*
23. Participants with alanine aminotransferase (ALT) values \>1.2× upper limit of normal (ULN) at screening or Day -1.
24. Participants who donated blood or plasma recently\*
25. 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.

Contacts and Locations

Study Locations (Sites)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2025-05-13

Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

ALG-097558
Dabigatran
Drug-Drug Interaction
Healthy Subjects
Interventional
Itraconazole
SARS-CoV-2
Tablet Formulation

Additional Relevant MeSH Terms

COVID-19