ALG-097558 for Coronavirus

Overseen By Steven Hull

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Amphetamines, Barbiturates, Narcotics, others

Disqualifiers: Cardiac disease, Drug allergy, Viral infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

51 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Healthy adults aged 18-65, nonsmokers for at least 3 months, with a BMI of 18.0 to 32.0 kg/m^2 can join this trial. Women must be postmenopausal, permanently sterile or using effective birth control; men must use condoms during the study and not donate sperm for 90 days after.

Inclusion Criteria

I can read and agree to follow the study rules and attend all visits.

I am a woman who is either postmenopausal, cannot have children, or use reliable birth control.

I am unable to have children due to a permanent procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A - Drug-Drug Interaction Evaluation

Evaluate the effect of itraconazole on the pharmacokinetics of ALG-097558 and its metabolite

10 days

Multiple visits for dosing and monitoring

Part B - Drug-Drug Interaction Evaluation

Evaluate the effect of ALG-097558 on the pharmacokinetics of dabigatran

5 days

Multiple visits for dosing and monitoring

Part C - Bioavailability and Food Effect Study

Study the bioavailability of ALG-097558 and the effect of food on its pharmacokinetics

7 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALG-097558

Trial Overview The trial is testing ALG-097558's interactions with other drugs (itraconazole and dabigatran) and how food affects its absorption in new tablet forms. It's divided into three parts: drug interaction risks, bioavailability of different formulations, and the impact of food intake.

Participant Groups

Group I: Part C Sequence 3 Arm Experimental Treatment 1 Intervention

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)

Group II: Part C Sequence 2 Arm Experimental Treatment 1 Intervention

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)

Group III: Part C Sequence 1 Arm Experimental Treatment 1 Intervention

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)

Group IV: Part B Arm Experimental Treatment 2 Interventions

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)

Group V: Part A Arm Experimental Treatment 3 Interventions

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)

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+