A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-04

Study Completion Date

2024-04-29

Brief Summary

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A multi-part study of ALG-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parts 1 and 2 of the study are parallel assignment, with 2 arms. Parts 3, 5, and 6 are fixed sequence, crossover studies. Part 4 is a partially placebo-controlled, fixed sequence, crossover study.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Parts 1 and 2 are double blinded and randomized. Parts 3, 5, and 6 are open label and non-randomized. Part 4 is partially singled blinded non-randomized. Participants are blinded.

Study Groups

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ALG-097558 Bioavailability

Oral doses of ALG-097558, up to 3 doses over 3 days, both solution and tablet formulations dosed in fasted state, and tablet formulation dosed in fed state, in Healthy Volunteers

Group Type EXPERIMENTAL

ALG-097558 in solution formulation

Intervention Type DRUG

ALG-097558 in solution administered in fasted state

ALG-097558 in tablet formulation

Intervention Type DRUG

ALG-097558 in tablet administered in fasted and fed state

ALG-097558

Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days

Group Type EXPERIMENTAL

ALG-097558

Intervention Type DRUG

single or multiple doses of ALG-097558

Placebo

Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single or multiple doses of placebo

ALG-097558 and Midazolam

Oral doses of ALG-097558, up to 14 doses over 7 days and oral dose of Midazolam, up to 2 doses, over 2 days, in Healthy Volunteers

Group Type EXPERIMENTAL

ALG-097558

Intervention Type DRUG

single or multiple doses of ALG-097558

Midazolam

Intervention Type DRUG

Multiple doses of Midazolam

ALG-097558, Placebo, and, Itraconazole

Oral doses of placebo, up to 2 doses over 2 days, followed by ALG-097558, up to 2 doses over 2 days, and itraconazole up to 10 doses over 10 days, in Healthy Volunteers.

Group Type EXPERIMENTAL

ALG-097558

Intervention Type DRUG

single or multiple doses of ALG-097558

Placebo

Intervention Type DRUG

single or multiple doses of placebo

Itraconazole

Intervention Type DRUG

Multiple doses of Itraconazole

ALG-097558 and Carbamazepine

Oral doses of ALG-097558, up to 2 doses over 2 days and oral doses of Carbamazepine, up to 30 doses, over 15 days, in Healthy Volunteers

Group Type EXPERIMENTAL

ALG-097558

Intervention Type DRUG

single or multiple doses of ALG-097558

Carbamazepine

Intervention Type DRUG

Multiple doses of Carbamazepine

Interventions

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ALG-097558

single or multiple doses of ALG-097558

Intervention Type DRUG

Placebo

single or multiple doses of placebo

Intervention Type DRUG

Midazolam

Multiple doses of Midazolam

Intervention Type DRUG

Itraconazole

Multiple doses of Itraconazole

Intervention Type DRUG

Carbamazepine

Multiple doses of Carbamazepine

Intervention Type DRUG

ALG-097558 in solution formulation

ALG-097558 in solution administered in fasted state

Intervention Type DRUG

ALG-097558 in tablet formulation

ALG-097558 in tablet administered in fasted and fed state

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and Female between 18 and 55 years old
2. BMI 18.0 to 32.0 kg/m\^2
3. Female subjects must have a negative serum pregnancy test at screening
4. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

Exclusion Criteria

1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
3. Subjects with a history of clinically significant drug allergy
4. Excessive use of alcohol defined as regular consumption of ≥14 units/week
5. Unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up
6. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
7. Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes