Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALG-097558 | Experimental | Oral doses of ALG-097558 in Healthy Volunteers, up to 20 doses over 10 days |
|
| Placebo | Placebo Comparator | Oral doses of placebo in Healthy Volunteers, up to 20 doses over 10 days |
|
| ALG-097558 and Midazolam | Experimental | 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 |
|
| ALG-097558, Placebo, and, Itraconazole | Experimental | 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. |
|
| ALG-097558 and Carbamazepine | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALG-097558 | Drug | single or multiple doses of ALG-097558 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 11 days for Part 1 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 20 days for Part 2 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 20 days for Part 3 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 23 days for Part 4 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 28 days for Part 5 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 17 days for Part 6 |
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of Midazolam and applicable metabolites |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-097558 in plasma |
Not provided
Inclusion Criteria for All Subjects:
Exclusion Criteria for All Subjects:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| ALG-097558 Bioavailability | Experimental | 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 |
|
| Placebo | Drug | single or multiple doses of placebo |
|
| Midazolam | Drug | Multiple doses of Midazolam |
|
| Itraconazole | Drug | Multiple doses of Itraconazole |
|
| Carbamazepine | Drug | Multiple doses of Carbamazepine |
|
| ALG-097558 in solution formulation | Drug | ALG-097558 in solution administered in fasted state |
|
| ALG-097558 in tablet formulation | Drug | ALG-097558 in tablet administered in fasted and fed state |
|
| Predose (-2 hours) up to 11 days |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days |
| Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days |
| Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days |
| C0 [predose] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days |
| Half-life [t1/2] | Pharmacokinetic parameters of Midazolam and applicable metabolites | Predose (-2 hours) up to 11 days |
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days |
| Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days |
| Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days |
| C0 [predose] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days |
| Half-life [t1/2] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of itraconazole or carbamazepine | Predose (-0.75 hours) up to 19 days |
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days |
| Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days |
| Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days |
| C0 [predose] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days |
| Half-life [t1/2] | Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 following administration of ALG-097558 in either solution or tablet formulations and following a high fat diet | Predose (-0.75 hours) up to 9 days |
| Predose (-0.75 hours) up to 19 days |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
| Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
| Half-life [t1/2] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
| C0 [predose] | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
| Dose Proportionality | Pharmacokinetic parameters of ALG-097558 in plasma | Predose (-0.75 hours) up to 19 days |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
Not provided