Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in… (NCT06945276) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers
United States51 participantsStarted 2025-05-13
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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\*\*\*.
✓. Male participants who must agree to wear a condom with spermicide during sexual intercourse.\*
✓. 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.\*
Exclusion criteria
✕. Participants must be deemed to be in good overall health by the Investigator on the basis of a medical evaluation\* performed at Screening.
What they're measuring
1
Area under the concentration-time curve from time zero to infinity [extrapolated] (AUC0-inf)
Timeframe: Up to Day 10
2
Area under the concentration-time curve from time zero to the last measurable concentration (AUClast)
Timeframe: Up to Day 10
3
Elimination half-life (t1/2)
Timeframe: Up to Day 10
4
Initial concentration (C0)
Timeframe: Up to Day 10
5
Maximum observed concentration (Cmax)
Timeframe: Up to Day 10
6
Minimum observed concentration (Cmin)
Timeframe: Up to Day 10
7
Time of observed maximum concentration (Tmax)
Timeframe: Up to Day 10
Trial details
NCT IDNCT06945276
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Subject must be willing and able to adhere to the Prohibited Medication requirements and Special Precautions as specified in the protocol.
✕. 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.\*
✕. 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.\*
✕. Excessive use of alcohol defined as regular consumption of \>/=14 standard drinks/week .\*
✕. Unwilling to abstain from alcohol use for 1 week prior to start of study through end of study follow up.